Post-market Clinical Follow-up of a Magnetic Bone Conduct... | NCT02022085

Post-market Clinical Follow-up of a Magnetic Bone Conduct... | NCT02022085 | Trialant

Description Module

Detailed Description

This investigation was designed to collect data regarding the usability and clinical performance of the Baha Attract System in subjects with hearing impairment that were candidates for Baha surgery.

The investigation was performed in an open design since it was not possible to perform the investigation in a blinded fashion. The main evaluations of the investigation, i.e. free-field hearing tests, are standard audiological procedures that are routinely used in daily clinical practice at hospitals worldwide for evaluation of hearing performance in hearing impaired patients. The primary efficacy evaluation, audiometric thresholds, renders comparable results across different sites and countries as it is not a language-specific test. Language-specific audiological tests were performed as secondary efficacy evaluations; to enable comparison of data across sites, validated word lists were used at all sites and equivalent speaker configurations (speech from front, noise from behind) and test procedures (same noise and adaptive speech levels, etc) were used.

For the primary evaluation in the investigation, the Baha Attract System was compared to the pre-operative unaided situation, as the intended use of the system is to improve hearing performance in patients with conductive or mixed hearing loss or single-sided sensorineural deafness. Audiological test results with the Baha Attract System were also compared against results obtained with the same Sound Processor on a Baha Softband. Use of the Sound Processor on a Softband is a standard procedure that is routinely used as a pre-operative test prior to bone conduction hearing implant surgery. The Softband test allows the patient to pre-operatively experience hearing through the Sound Processor to get an indication of the post-operative hearing outcome and to choose a suitable Sound Processor.

The generic and hearing-specific quality of life questionnaires used in the investigation (HUI3, APHAB, SSQ) are validated scales that have been frequently used and reported in the literature.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Baha Attract System	Experimental	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)	Device: Baha Attract System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Baha Attract System	Device	The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hearing Performance: Threshold Audiometry PTA4: Unaided Versus Baha Attract	The change of hearing performance with the Baha Attract System (aided) at 6, 12 and 24 months from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz). The units reported for PTA4 are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.	Baseline (unaided) before surgery, 6, 12 and 24 months after surgery
Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract	The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz). The units reported for PTA4 are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.	Baseline (unaided) before surgery, 24 months after surgery
Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract	The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry at frequencies of 250, 500, 1000, 2000, 3000, 4000 and 6000 Hz). The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.	Baseline (unaided) before surgery, 12 months after surgery
Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract	The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry at individual frequencies 250, 500, 1000, 2000, 3000, 4000 and 6000 Hz. The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.

Secondary Outcomes

Measure	Description	Time Frame
Adaptive Speech Recognition in Noise Ratio: Unaided Versus Baha Attract	The change of hearing performance with the Baha Attract System compared to the pre-operative unaided situation; Adaptive speech recognition in noise measured as signal to noise ratio The adaptive speech test in noise was conducted using validated lists of phonetically balanced sentences, with speech presented from the front (0 degrees azimuth) and noise from the back (180 degrees azimuth). The noise was kept constant at 65 dB SPL, and the speech was adapted in 2 dB steps to establish the speech-to-noise ratio (SNR) providing a 50% level of understanding. A ratio of 1 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A lower ratio than 1 reflects the ability to correctly hear sentences below 65 dB. A ratio higher than 1 reflects the ability to correctly hear sentences presented above 65 dB. Manchester and Birmingham are excluded from this analysis due to incorrect set up.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Johan Blechert, M.Sc	Cochlear Bone Anchored Solutions AB	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Dr. Doug Backhus		Seattle	Washington	98122	United States
Christina Runge

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Baha Attract System	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 22, 2013	Aug 27, 2018

Arm/Group Information

ID	Title	Description
BG000	Baha Attract System	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.

Units	Counts
Participants	BG00054

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00042.1± 13.6

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00033
Male	BG00021

Region of Enrollment

Number

participants

Title

Denominators

Categories

Netherlands

Title	Measurements
	BG00023

United States

Title	Measurements
	BG000

Type of hearing loss

Number

participants

Title

Denominators

Categories

Conductive hearing loss

Title	Measurements
	BG00039

Single-sided sensorineural deafness

Title	Measurements
	BG000

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Hearing Performance: Threshold Audiometry PTA4: Unaided Versus Baha Attract

The change of hearing performance with the Baha Attract System (aided) at 6, 12 and 24 months from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz).

The units reported for PTA4 are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.

Intention-to-Treat (ITT) population; includes all subjects who received the surgical intervention.

Posted

Mean

Standard Deviation

Baseline (unaided) before surgery, 6, 12 and 24 months after surgery

ID	Title	Description
OG000	Baha Attract System	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.

Units	Counts
Participants	OG00054

Title

Denominators

Categories

PTA4 6 months, Baha Attract vs Unaided

- ParticipantsOG00054

Title	Measurements
	OG000-21.0± 10.4

PTA4 12 months, Baha Attract vs Baha Attract

- ParticipantsOG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000	PTA4 6 months with Baha Attract vs Unaided	Fisher's non-parametric permutation test		<0.0001						2-Sided	95							Superiority or Other
OG000	PTA4 12 months with Baha Attract vs Unaided	Fisher's non-parametric permutation test

Primary

Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract

The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz).

The units reported for PTA4 are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.

Intention-to-Treat population (ITT); includes all subjects who received the surgical intervention.

Posted

Mean

Standard Deviation

Baseline (unaided) before surgery, 24 months after surgery

ID	Title	Description
OG000	Baha Attract System	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.

Primary

Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract

The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.

Intention-to-Treat population (ITT); includes all subjects who received the surgical intervention.

Posted

Mean

Standard Deviation

Baseline (unaided) before surgery, 12 months after surgery

ID	Title	Description
OG000	Baha Attract System	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.

Primary

Hearing Performance: Change in Threshold Audiometry: Unaided Versus Baha Attract

The change of hearing performance with the Baha Attract System (aided) from the unaided hearing performance before surgery; measured as free-field hearing tests:

Threshold audiometry at individual frequencies 250, 500, 1000, 2000, 3000, 4000 and 6000 Hz.

The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.

Intention-to-Treat population (ITT); includes all subjects who received the surgical intervention.

Posted

Mean

Standard Deviation

Baseline (unaided) before surgery, 6 months after surgery

ID	Title	Description
OG000	Baha Attract System	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.

Secondary

Adaptive Speech Recognition in Noise Ratio: Unaided Versus Baha Attract

The change of hearing performance with the Baha Attract System compared to the pre-operative unaided situation; Adaptive speech recognition in noise measured as signal to noise ratio

The adaptive speech test in noise was conducted using validated lists of phonetically balanced sentences, with speech presented from the front (0 degrees azimuth) and noise from the back (180 degrees azimuth). The noise was kept constant at 65 dB SPL, and the speech was adapted in 2 dB steps to establish the speech-to-noise ratio (SNR) providing a 50% level of understanding.

A ratio of 1 reflects the ability to correctly hear sentences at 65 dB, in the presence of 65 dB background noise. A lower ratio than 1 reflects the ability to correctly hear sentences below 65 dB. A ratio higher than 1 reflects the ability to correctly hear sentences presented above 65 dB.

Manchester and Birmingham are excluded from this analysis due to incorrect set up.

Intention-to-Treat (ITT) population; includes all patient who received the surgical intervention.

Adaptive Speech in Noise analysis excluded subjects from Birmingham and Manchester clinics due to incorrect set up.

Posted

Mean

Standard Deviation

Baseline (unaided) before surgery, 6, 12 and 24 months after surgery

ID	Title	Description
OG000	Baha Attract System	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.

Secondary

Speech in Quiet, Baha Attract Versus Unaided

The change of hearing performance with the Baha Attract System at 6, 12 and 24 months compared to the pre-operative unaided situation; Speech in quiet at 50, 65 and 80dB.

Speech in Quiet is a measure of percentage of correct words. A higher score reflects a higher percentage of correct words.

Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.

Posted

Mean

Standard Deviation

Change of % correct words at the dB leve

Baseline before surgery, 6, 12 and 24 months after surgery

ID	Title	Description
OG000	Baha Attract System	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.

Units

Secondary

Hearing Performance: Threshold Audiometry PTA4: Sound Processor on Softband Versus Baha Attract

The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance, sound processor on a softband, before surgery; measured as free-field hearing tests: Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz)

The units reported for PTA4 are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.

Intention-to-Treat (ITT) population; includes all subjects who received the surgical intervention.

Posted

Mean

Standard Deviation

Baseline before surgery, 6, 12 and 24 months after surgery

ID	Title	Description
OG000	Baha Attract System	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.

Secondary

Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband

The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance with Sound processor on a Softband before surgery; measured as free-field hearing tests:

Threshold audiometry at individual frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 Hz.

The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.

Intention-to-Treat population (ITT); includes all subjects who received the surgical intervention.

Posted

Mean

Standard Deviation

Baseline (aided) before surgery, 6 months after surgery

ID	Title	Description
OG000	Baha Attract System	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.

Secondary

Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband

The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance with Sound processor on a Softband before surgery; measured as free-field hearing tests:

Threshold audiometry at individual frequencies: 250, 500, 1000, 2000, 3000, 4000, 6000 Hz.

The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.

Intention-to-Treat population (ITT); includes all subjects who received the surgical intervention.

Posted

Mean

Standard Deviation

Baseline (aided) before surgery, 12 months after surgery

ID	Title	Description
OG000	Baha Attract System	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.

Secondary

Hearing Performance: Threshold Audiometry Individual Frequencies: Baha Attract Versus Sound Processor on Softband

The change of hearing performance with the Baha Attract System (aided) from the aided hearing performance with Sound processor on a Softband before surgery; measured as free-field hearing tests:

Threshold audiometry at individual frequencies: 250, 500, 1000, 2000, 3000, 4000, 6000 Hz.

The units reported for threshold audiometry are decibels (dB). As such, a lower or more negative score is more desirable and reflects the ability to hear softer sounds.

Intention-to-Treat population (ITT); includes all subjects who received the surgical intervention.

Posted

Mean

Standard Deviation

Baseline (aided) before surgery, 24 months after surgery

ID	Title	Description
OG000	Baha Attract System	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.

Secondary

Adaptive Speech Recognition in Noise Ratio: Baha Attract Versus Sound Processor on Softband

The change of hearing performance with the Baha Attract System compared to the pre-operative aided situation with Sound Processor on a softband; Adaptive Speech recognition in Noise measured as signal to noise ratio.

Intention-to-Treat (ITT) population; includes all patient who received the surgical intervention.

Speech in Noise analysis excludes patients from Birmingham and Manchester due to incorrect set up.

Posted

Mean

Standard Deviation

change in SNR dB

Baseline (aided) before surgery, 6, 12 and 24 months after surgery

ID	Title	Description
OG000	Baha Attract System	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.

Secondary

Speech in Quiet: Baha Attract Versus Sound Processor on Softband

The change of hearing performance with the Baha Attract System at 6 months compared to the pre-operative aided situation with the Sound Processor on a softband; Speech in quiet at 50, 65 and 80dB.

Speech in Quiet is a measure of percentage of correct words. A higher score reflects a higher percentage of correct words.

Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.

Posted

Mean

Standard Deviation

Change of % correct words at the dB leve

Baseline (aided) before surgery, 6, 12 and 24 months after surgery

ID	Title	Description
OG000	Baha Attract System	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.

Secondary

Health Utility Index (HUI)

Change of health status and health related quality of life using the generic quality of life scale Health Utilities Index (HUI3) when wearing Baha Attract System compared to the pre-operative unaided situation. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change from unaided to aided hearing is presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.

HUI score of 1 (maximum) describes a state of perfect health. HUI score of 0 describes a state of dead. A negative score of Comprehensive Health State describes a state worse than dead.

Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.

Posted

Mean

Standard Deviation

units on a scale

Baseline (unaided) before surgery, 6 and 24 months after surgery

ID	Title	Description
OG000	Baha Attract System	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.

Secondary

Abbreviated Profile of Hearing Aid Benefit (APHAB)

Measuring change of Ease of communication, Reverberation, Background noise, Aversiveness and a Global score with the Baha Attract System from the pre-operative unaided situation. The absolute APHAB scale is between 0 and 100%, where 0% indicates no problems and 100% indicates always problem. The change from unaided to aided hearing is presented. A positive value indicates an improvement, a negative value an impairment.

Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.

Posted

Mean

Standard Deviation

units on scale

Baseline before surgery, 6 and 24 months after surgery

ID	Title	Description
OG000	Baha Attract System	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.

Secondary

Speech, Spatial and Qualities of Hearing Scale (SSQ)

Measuring change of speech, spatial and hearing experiences with the Baha Attract System from the pre-operative unaided situation. A scale from 0 to 10, where 0 represents "can not hear at all", and 10 "hear perfectly". The change from unaided to aided hearing is presented. A positive value indicates improved hearing, a negative value indicates impaired hearing.

Intention-to-Treat (ITT) population; includes all patient who received the surgical intervention.

Posted

Mean

Standard Deviation

units on scale

Baseline before surgery, 6 and 24 months after surgery

ID	Title	Description
OG000	Baha Attract System	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.

Secondary

Time to Perform Surgery

Time of first incision to time of last suture

Intention-to-Treat (ITT) population; includes all patients who received the surgical intervention.

Posted

Mean

Standard Deviation

Minutes

Visit 2 (Surgery)

ID	Title	Description
OG000	Baha Attract System	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.

Units	Counts
Participants	OG000

Secondary

Tissue Reduction Performed During Surgery

Surgical thinning of the soft tissue flap was advocated when the soft tissue thickness exceeded 6 mm

Intention-to-Treat (ITT) population; all patients who received surgical intervention.

Posted

Number

participants

Visit 2 (surgery)

ID	Title	Description
OG000	Baha Attract System	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.

Units	Counts
Participants

Secondary

Implant Stability

Implant Stability Quotient - ISQ, a scale from 1 to 100, where 100 represent the highest stability

Intention-to-treat (ITT) population; includes all patients who received surgical intervention.

Posted

Mean

Standard Deviation

units on a scale

Visit 2 (surgery)

ID	Title	Description
OG000	Baha Attract System	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.

Units	Counts
Participants

Secondary

Magnetic Force

To investigate if the magnetic force required for sound processor magnet retention will change over time

Intention-to-Treat (ITT) population; includes all patients who received surgical intervention.

Posted

Mean

Standard Deviation

Newton

4, 6, 12 weeks, 6, 12 and 24 months

ID	Title	Description
OG000	Baha Attract System	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.

Units	Counts
Participants

Secondary

Sound Processor Magnet Choice

To investigate how sound processor magnet choice will change over time. Six different magnetic strength could be chosen; SPM 1 had the lowest strength and SPM 6 the the highest.

Intention-to-Treat (ITT) population; includes all patients who received surgical intervention at week 4. At week 6, 12 and month 6, 12 and 24 one patient had left the study.

Posted

Count of Participants

Participants

4, 6, 12 weeks, 6, 12 and 24 months

ID	Title	Description
OG000	Baha Attract System	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.

Units	Counts
Participants

Secondary

Pain & Discomfort

Degree of pain and discomfort.

Safety population; includes all patients who received the surgical intervention.

Posted

Count of Participants

Participants

Week 6, Week 12, Month 6, Month 12, Month 24

ID	Title	Description
OG000	Baha Attract System	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.

Units	Counts
Participants	OG000

Secondary

Numbness When Tested With a Pin

Degree of numbness when tested with a pin

Safety population; includes all patients who received the surgical intervention.

Posted

Count of Participants

Participants

Day 10, Week 4, Week 6, Week 12, Month 6, Month 12, Month 24

ID	Title	Description
OG000	Baha Attract System	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.

Units	Counts
Participants	OG000

Secondary

Numbness When Tested With a Cotton Swab

Degree of numbness when tested with a Cotton Swab

Safety population; includes all patients who received the surgical intervention.

Posted

Count of Participants

Participants

Day 10, Week 4, Week 6, Week 12, Month 6, Month 12, Month 24

ID	Title	Description
OG000	Baha Attract System	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Baha Attract System	This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin; One implant magnet One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet) Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.	1	54	13	54	29	54

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Infection	Infections and infestations	CTCAE (4.03)	Systematic Assessment	Adverse Event Term is the Reported term	EG0001 events1 affected54 at risk
Increase in instability of knee prosthesis	General disorders	CTCAE (4.03)	Systematic Assessment	Adverse Event Term is the Reported term	EG0001 events1 affected54 at risk
Pancreatitis	Gastrointestinal disorders	CTCAE (4.03)	Systematic Assessment	Adverse Event Term is the Reported term	EG0001 events1 affected54 at risk
Embolisation of the Splenic Artery from pancreatitis	Blood and lymphatic system disorders	CTCAE (4.03)	Systematic Assessment	Adverse Event Term is the Reported term	EG0001 events1 affected54 at risk
Increase of Meniere Attacks	Ear and labyrinth disorders	CTCAE (4.03)	Systematic Assessment	Adverse Event Term is the Reported term	EG0001 events1 affected54 at risk
Progression of Hearing Loss	Ear and labyrinth disorders	CTCAE (4.03)	Systematic Assessment	Adverse Event Term is the Reported term	EG0001 events1 affected54 at risk
Decompensated Alcoholic Liver Disease	Hepatobiliary disorders	CTCAE (4.03)	Systematic Assessment	Adverse Event Term is the Reported term	EG0001 events1 affected54 at risk
Broken Ankle	Injury, poisoning and procedural complications	CTCAE (4.03)	Systematic Assessment	Adverse Event Term is the Reported term	EG0001 events1 affected54 at risk
Cholesteatoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	CTCAE (4.03)	Systematic Assessment	Adverse Event Term is the Reported term	EG0001 events1 affected54 at risk
Pain/Discomfort	Injury, poisoning and procedural complications	CTCAE (4.03)	Systematic Assessment	Adverse Event Term is the Reported term	EG0001 events1 affected54 at risk
Surgery for Baha Attract on other ear	Surgical and medical procedures	CTCAE (4.03)	Systematic Assessment	Adverse Event Term is the Reported term	EG0001 events1 affected54 at risk
Increase in Occlusive Arterial Disease	Vascular disorders	CTCAE (4.03)	Systematic Assessment	Adverse Event Term is the Reported term	EG0001 events1 affected54 at risk
Dequervian	Musculoskeletal and connective tissue disorders	CTCAE (4.03)	Systematic Assessment	Adverse Event Term is the Reported term	EG0001 events1 affected54 at risk
Patient was addmitted to the hospital due to childbirth	Pregnancy, puerperium and perinatal conditions	CTCAE (4.03)	Systematic Assessment	Adverse Event Term is the Reported term	EG0001 events1 affected54 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Ear and Labyrinth Disorders	Ear and labyrinth disorders	CTCAE (4.03)	Systematic Assessment	EG0009 events6 affected54 at risk
Gastrointestinal Disorders	Gastrointestinal disorders	CTCAE (4.03)	Systematic Assessment	EG0005 events4 affected54 at risk
General Disorders and Administration Site Conditions	General disorders	CTCAE (4.03)	Systematic Assessment	EG00010 events10 affected54 at risk
Infections and Infestation	Infections and infestations	CTCAE (4.03)	Systematic Assessment	EG00021 events14 affected54 at risk
Injury, Poisoning and Procedural Complications	Infections and infestations	CTCAE (4.03)	Systematic Assessment	EG0005 events5 affected54 at risk
Musculoskeletal and Connective Tissue Disorders	Musculoskeletal and connective tissue disorders	CTCAE (4.03)	Systematic Assessment	EG0004 events4 affected54 at risk
Nervous System Disorders	Nervous system disorders	CTCAE (4.03)	Systematic Assessment	EG0005 events5 affected54 at risk
Respiratory, Thoracic and Mediastinal Disorders	Respiratory, thoracic and mediastinal disorders	CTCAE (4.03)	Systematic Assessment	EG0003 events3 affected54 at risk
Skin and Subcutaneous Tissue Disorders	Skin and subcutaneous tissue disorders	CTCAE (4.03)	Systematic Assessment	EG0007 events7 affected54 at risk
Vascular Disorders	Vascular disorders	CTCAE (4.03)	Systematic Assessment	EG0003 events3 affected54 at risk
Predefined event: Pressure related Skin Complications	Skin and subcutaneous tissue disorders	CTCAE (4.03)	Systematic Assessment	EG0006 events6 affected54 at risk
Predefined event: Pain/Discomfort	Skin and subcutaneous tissue disorders	CTCAE (4.03)	Systematic Assessment	EG00037 events24 affected54 at risk

Ancestor Terms

ID	Term
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Title

Denominators

Categories

Change of Threshold value at 250 Hz

- ParticipantsOG00045

Title	Measurements
	OG000-19.9± 11.0

Change of Threshold value at 500 Hz

- ParticipantsOG00046

Title	Measurements
	OG000-25.3± 9.6

Change of Threshold value at 1000 Hz

- ParticipantsOG00046

Title	Measurements
	OG000-28.0± 12.4

Change of Threshold value at 2000 Hz

- ParticipantsOG00046

Title	Measurements
	OG000-19.6± 11.8

Change of Threshold value at 3000 Hz

- ParticipantsOG00046

Title	Measurements
	OG000-18.4± 10.9

Change of Threshold value at 4000 Hz

- ParticipantsOG00046

Title	Measurements
	OG00013.2± 12.0

Change of Threshold value at 6000 Hz

- ParticipantsOG00045

Title	Measurements
	OG000-8.67± 8.88

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000	Baha Attract after 24 months vs Unaided situation Pre-Op	Fisher's non-parametric permutation test		<0.0001	All comparisons to the Unaided situation were p=<0.0001.													Superiority or Other

Title

Denominators

Categories

Change of Threshold value at 250 Hz

Title	Measurements
	OG000-18.5± 14.3

Change of Threshold value at 500 Hz

Title	Measurements
	OG000-26.0± 13.0

Change of Threshold value at 1000 Hz

Title	Measurements
	OG000-26.5± 14.2

Change of Threshold value at 2000 Hz

Title	Measurements
	OG000-18.5± 13.5

Change of Threshold value at 3000 Hz

Title	Measurements
	OG000-16.3± 13.2

Change of Threshold value at 4000 Hz

Title	Measurements
	OG000-12.5± 12.2

Change of Threshold value at 6000 Hz

Title	Measurements
	OG000-7.25± 11.19

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000	Baha Attract after 12 months vs Unaided situation Pre-Op	Fisher's non-parametric permutation test		<0.0001	All comparisons to the Unaided situation were p=<0.0001.													Superiority or Other

Title

Denominators

Categories

Change of Threshold value at 250 Hz

Title	Measurements
	OG000-16.9± 12.9

Change of Threshold value at 500 Hz

Title	Measurements
	OG000-26.6± 12.8

Change of Threshold value at 1000 Hz

Title	Measurements
	OG000-26.4± 14.1

Change of Threshold value at 2000 Hz

Title	Measurements
	OG000-18.7± 12.1

Change of Threshold value at 3000 Hz

Title	Measurements
	OG000-16.9± 12.7

Change of Threshold value at 4000 Hz

Title	Measurements
	OG000-12.3± 10.6

Change of Threshold value at 6000 Hz

Title	Measurements
	OG000-7.04± 8.61

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000	Baha Attract after 6 months vs Unaided situation Pre-Op	Fisher's non-parametric permutation test		<0.0001	All comparisons to the Unaided situation were p=<0.0001.					2-Sided	95							Superiority or Other

Title

Denominators

Categories

SNR 6 months, Baha Attract vs Unaided

- ParticipantsOG00036

Title	Measurements
	OG000-4.30± 5.64

SNR 12 months, Baha Attract vs Unaided

- ParticipantsOG00035

Title	Measurements
	OG0004.79± 6.17

SNR 24 months, Baha Attract vs Unaided

- ParticipantsOG00031

Title	Measurements
	OG000-4.47± 6.11

Group IDs	Group Description	Statistical Method	P-Value	Confidence Interval Sides	Confidence Interval %	Non-Inferiority Type
OG000	Speech in Noise, 6 months Baha Attract vs Unaided	Fisher's non-parametric permutation test	<0.0001	2-Sided	95	Superiority or Other
OG000	Speech in Noise, 12 months Baha Attract vs Unaided	Fisher's non-parametric permutation test	<0.0001			Superiority or Other
OG000	Speech in Noise, 24 months Baha Attract vs Unaided	Fisher's non-parametric permutation test	<0.0001			Superiority or Other

Title

Denominators

Categories

6 months: Speech in quiet at 50dB

- ParticipantsOG00054

Title	Measurements
	OG00052.1± 29.2

6 months: Speech in quiet at 65dB

- ParticipantsOG00054

Title	Measurements
	OG00043.4± 31.5

6 months: Speech in quiet at 80dB

- ParticipantsOG00054

Title	Measurements
	OG00013.3± 20.6

12 months: Speech in quiet at 50dB

- ParticipantsOG00051

Title	Measurements
	OG00050.7± 30.2

12 months: Speech in quiet at 65dB

- ParticipantsOG00051

Title	Measurements
	OG00045.5± 31.4

12 months: Speech in quiet at 80dB

- ParticipantsOG00051

Title	Measurements
	OG00013.9± 21.2

24 months: Speech in quiet at 50dB

- ParticipantsOG00046

Title	Measurements
	OG00040.4± 33.3

24 months: Speech in quiet at 65dB

- ParticipantsOG00046

Title	Measurements
	OG00043.3± 29.9

24 months: Speech in quiet at 80dB

- ParticipantsOG00046

Title	Measurements
	OG00014.0± 20.7

Group IDs	Group Description	Statistical Method	P-Value	Confidence Interval Sides	Confidence Interval %	Non-Inferiority Type
OG000	6 months: Speech in quiet at 50dB	Fisher's non-parametric permutation test	<0.0001	2-Sided	95	Superiority or Other
OG000	6 months: Speech in quiet at 65dB	Fisher's non-parametric permutation test	<0.0001			Superiority or Other
OG000	6 months: Speech in quiet at 80dB	Fisher's non-parametric permutation test	<0.0001			Superiority or Other
OG000	12 months: Speech in quiet at 50dB	Fisher's non-parametric permutation test	<0.0001			Superiority or Other
OG000	12 months: Speech in quiet at 65dB	Fisher's non-parametric permutation test	<0.0001			Superiority or Other
OG000	12 months: Speech in quiet at 80dB	Fisher's non-parametric permutation test	<0.0001			Superiority or Other
OG000	24 months: Speech in quiet at 50dB	Fisher's non-parametric permutation test	<0.0001			Superiority or Other
OG000	24 months: Speech in quiet at 65dB	Fisher's non-parametric permutation test	<0.0001			Superiority or Other
OG000	24 months: Speech in quiet at 80dB	Fisher's non-parametric permutation test	<0.0001			Superiority or Other

Title

Denominators

Categories

6 months vs Softband: PTA4

- ParticipantsOG00054

Title	Measurements
	OG000-0.62± 5.138

12 months vs Softband: PTA4

- ParticipantsOG00051

Title	Measurements
	OG0000.196± 6.719

24 months vs Softband: PTA4

- ParticipantsOG00046

Title	Measurements
	OG000-0.136± 6.472

Group IDs	Group Description	Statistical Method	P-Value	Confidence Interval Sides	Confidence Interval %	Non-Inferiority Type
OG000	6 months with Baha Attract vs Softband: change in PTA4	Fisher's non-parametric permutation test	0.38	2-Sided	95	Superiority or Other
OG000	12 months with Baha Attract vs Softband: change in PTA4	Fisher's non-parametric permutation test	0.84			Superiority or Other
OG000	24 months with Baha Attract vs Softband: change in PTA4	Fisher's non-parametric permutation test	0.89			Superiority or Other

Title

Denominators

Categories

6 months: Change of Threshold value at 250 Hz

Title	Measurements
	OG000-1.30± 9.77

6 months: Change of Threshold value at 500 Hz

Title	Measurements
	OG000-4.17± 7.99

6 months: Change of Threshold value at 1000 Hz

Title	Measurements
	OG000-1.11± 6.49

6 months: Change of Threshold value at 2000 Hz

Title	Measurements
	OG000-0.463± 7.022

6 months: Change of Threshold value at 3000 Hz

Title	Measurements
	OG0002.69± 9.40

6 months: Change of Threshold value at 4000 Hz

Title	Measurements
	OG0003.24± 9.07

6 months: Change of Threshold value at 6000 Hz

Title	Measurements
	OG0005.56± 9.60

Group IDs	Group Description	Statistical Method	P-Value	Confidence Interval Sides	Confidence Interval %	Non-Inferiority Type
OG000	250Hz: 6 months with Baha Attract vs Softband	Fisher's non-parametric permutation test	0.34	2-Sided	95	Superiority or Other
OG000	500Hz: 6 months with Baha Attract vs Softband	Fisher's non-parametric permutation test	0.0004	2-Sided	95	Superiority or Other
OG000	1000Hz: 6 months with Baha Attract vs Softband	Fisher's non-parametric permutation test	0.22	2-Sided	95	Superiority or Other
OG000	2000Hz: 6 months with Baha Attract vs Softband	Fisher's non-parametric permutation test	0.64	2-Sided	95	Superiority or Other
OG000	3000Hz: 6 months with Baha Attract vs Softband	Fisher's non-parametric permutation test	0.039	2-Sided	95	Superiority or Other
OG000	4000Hz: 6 months with Baha Attract vs Softband	Fisher's non-parametric permutation test	0.012	2-Sided	95	Superiority or Other
OG000	6000Hz: 6 months with Baha Attract vs Softband	Fisher's non-parametric permutation test	<0.0001	2-Sided	95	Superiority or Other

Title

Denominators

Categories

12 months: Change of Threshold value at 250 Hz

Title	Measurements
	OG000-2.55± 11.15

12 months: Change of Threshold value at 500 Hz

Title	Measurements
	OG000-2.84± 10.74

12 months: Change of Threshold value at 1000 Hz

Title	Measurements
	OG000-0.392± 6.989

12 months: Change of Threshold value at 2000 Hz

Title	Measurements
	OG0000.392± 9.265

12 months: Change of Threshold value at 3000 Hz

Title	Measurements
	OG0004.02± 11.53

12 months: Change of Threshold value at 4000 Hz

Title	Measurements
	OG0003.63± 11.84

12 months: Change of Threshold value at 6000 Hz

Title	Measurements
	OG0005.59± 11.52

Group IDs	Group Description	Statistical Method	P-Value	Non-Inferiority Type
OG000	250Hz: 12 months with Baha Attract vs Softband	Fisher's non-parametric permutation test	0.11	Superiority or Other
OG000	500Hz: 12 months with Baha Attract vs Softband	Fisher's non-parametric permutation test	0.066	Superiority or Other
OG000	1000Hz: 12 months with Baha Attract vs Softband	Fisher's non-parametric permutation test	0.71	Superiority or Other
OG000	2000Hz: 12 months with Baha Attract vs Softband	Fisher's non-parametric permutation test	0.78	Superiority or Other
OG000	3000Hz: 12 months with Baha Attract vs Softband	Fisher's non-parametric permutation test	0.015	Superiority or Other
OG000	4000Hz: 12 months with Baha Attract vs Softband	Fisher's non-parametric permutation test	0.035	Superiority or Other
OG000	6000Hz: 12 months with Baha Attract vs Softband	Fisher's non-parametric permutation test	0.0013	Superiority or Other

Title

Denominators

Categories

24 months: Change of Threshold value at 250 Hz

- ParticipantsOG00045

Title	Measurements
	OG000-3.67± 8.35

24 months: Change of Threshold value at 500 Hz

- ParticipantsOG00046

Title	Measurements
	OG000-1.74± 10.23

24 months: Change of Threshold value at 1000 Hz

- ParticipantsOG00046

Title	Measurements
	OG000-1.20± 6.34

24 months: Change of Threshold value at 2000 Hz

- ParticipantsOG00046

Title	Measurements
	OG000-0.761± 8.690

24 months: Change of Threshold value at 3000 Hz

- ParticipantsOG00046

Title	Measurements
	OG0002.61± 9.23

24 months: Change of Threshold value at 4000 Hz

- ParticipantsOG00046

Title	Measurements
	OG0003.15± 11.17

24 months: Change of Threshold value at 6000 Hz

- ParticipantsOG00046

Title	Measurements
	OG0005.22± 11.72

Group IDs	Group Description	Statistical Method	P-Value	Non-Inferiority Type
OG000	250Hz: 24 months with Baha Attract vs Softband	Fisher's non-parametric permutation test	0.0051	Superiority or Other
OG000	500Hz: 24 months with Baha Attract vs Softband	Fisher's non-parametric permutation test	0.26	Superiority or Other
OG000	1000Hz: 24 months with Baha Attract vs Softband	Fisher's non-parametric permutation test	0.22	Superiority or Other
OG000	2000Hz: 24 months with Baha Attract vs Softband	Fisher's non-parametric permutation test	0.57	Superiority or Other
OG000	3000Hz: 24 months with Baha Attract vs Softband	Fisher's non-parametric permutation test	0.064	Superiority or Other
OG000	4000Hz: 24 months with Baha Attract vs Softband	Fisher's non-parametric permutation test	0.064	Superiority or Other
OG000	6000Hz: 24 months with Baha Attract vs Softband	Fisher's non-parametric permutation test	0.0051	Superiority or Other

Title

Denominators

Categories

6 months: Speech in Noise

- ParticipantsOG00038

Title	Measurements
	OG000-0.508± 4.173

12 months: Speech in Noise

- ParticipantsOG00037

Title	Measurements
	OG000-1.05± 4.75

24 months: Speech in Noise

- ParticipantsOG00033

Title	Measurements
	OG000-0.739± 4.106

Group IDs	Group Description	Statistical Method	P-Value	Confidence Interval Sides	Confidence Interval %	Non-Inferiority Type
OG000	6 months: Speech in Noise with Baha Attract vs Softband	Fisher's non-parametric permutation test	0.46	2-Sided	95	Superiority or Other
OG000	12 months: Speech in Noise with Baha Attract vs Softband	Fisher's non-parametric permutation test	0.19			Superiority or Other
OG000	24 months: Speech in Noise with Baha Attract vs Softband	Fisher's non-parametric permutation test	0.31			Superiority or Other

Title

Denominators

Categories

6 months: Speech in quiet at 50dB

- ParticipantsOG00054

Title	Measurements
	OG0002.74± 29.94

6 months: Speech in quiet at 65dB

- ParticipantsOG00054

Title	Measurements
	OG000-2.11± 10.62

6 months: Speech in quiet at 80dB

- ParticipantsOG00054

Title	Measurements
	OG000-0.33± 5.00

12 months: Speech in quiet at 50dB

- ParticipantsOG00051

Title	Measurements
	OG0000.373± 27.201

12 months: Speech in quiet at 65dB

- ParticipantsOG00051

Title	Measurements
	OG000-2.69± 11.16

12 months: Speech in quiet at 80dB

- ParticipantsOG00051

Title	Measurements
	OG000-0.961± 8.457

24 months: Speech in quiet at 50dB

- ParticipantsOG00046

Title	Measurements
	OG000-11.6± 32.6

24 months: Speech in quiet at 65dB

- ParticipantsOG00046

Title	Measurements
	OG000-5.67± 16.48

24 months: Speech in quiet at 80dB

- ParticipantsOG00046

Title	Measurements
	OG000-0.696± 8.178

Group IDs	Group Description	Statistical Method	P-Value	Confidence Interval Sides	Confidence Interval %	Non-Inferiority Type
OG000	6 months Speech in Quiet at 50dB	Fisher's non-parametric permutation test	0.43	2-Sided	95	Superiority or Other
OG000	6 months Speech in Quiet at 65dB	Fisher's non-parametric permutation test	0.16	2-Sided	95	Superiority or Other
OG000	6 months Speech in Quiet at 80dB	Fisher's non-parametric permutation test	0.65	2-Sided	95	Superiority or Other
OG000	12 months Speech in Quiet at 50dB	Fisher's non-parametric permutation test	0.93			Superiority or Other
OG000	12 months Speech in Quiet at 65dB	Fisher's non-parametric permutation test	0.094			Superiority or Other
OG000	12 months Speech in Quiet at 80dB	Fisher's non-parametric permutation test	0.44			Superiority or Other
OG000	24 months Speech in Quiet at 50dB	Fisher's non-parametric permutation test	0.021			Superiority or Other
OG000	24 months Speech in Quiet at 65dB	Fisher's non-parametric permutation test	0.024			Superiority or Other
OG000	24 months Speech in Quiet at 80dB	Fisher's non-parametric permutation test	0.59			Superiority or Other

Title

Denominators

Categories

6 months: Comprehensive health state

- ParticipantsOG00047

Title	Measurements
	OG0000.063± 0.249

6 months: Vision

- ParticipantsOG00053

Title	Measurements
	OG000-0.003± 0.033

6 months: Hearing

- ParticipantsOG00049

Title	Measurements
	OG0000.111± 0.321

6 months: Speech

- ParticipantsOG00052

Title	Measurements
	OG0000.045± 0.153

6 months: Ambulation

- ParticipantsOG00053

Title	Measurements
	OG000-0.016± 0.067

6 months: Dexterity

- ParticipantsOG00053

Title	Measurements
	OG000-0.021± 0.108

6 months: Emotion

- ParticipantsOG00053

Title	Measurements
	OG0000.017± 0.152

6 months: Cognition

- ParticipantsOG00052

Title	Measurements
	OG0000.005± 0.158

6 months: Pain

- ParticipantsOG00053

Title	Measurements
	OG0000.020± 0.123

24 months: Comprehensive health state

- ParticipantsOG00037

Title	Measurements
	OG0000.069± 0.240

24 months: Vision

- ParticipantsOG00046

Title	Measurements
	OG0000.002± 0.015

24 months: Hearing

- ParticipantsOG00039

Title	Measurements
	OG0000.119± 0.358

24 months: Speech

- ParticipantsOG00044

Title	Measurements
	OG0000.051± 0.135

24 months: Ambulation

- ParticipantsOG00046

Title	Measurements
	OG000-0.015± 0.076

24 months: Dexterity

- ParticipantsOG00044

Title	Measurements
	OG000-0.025± 0.151

24 months: Emotion

- ParticipantsOG00044

Title	Measurements
	OG0000.014± 0.089

24 months: Cognition

- ParticipantsOG00045

Title	Measurements
	OG0000.003± 0.134

24 months: Pain

- ParticipantsOG00045

Title	Measurements
	OG0000.040± 0.117

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	Confidence Interval Sides	Confidence Interval %	Non-Inferiority Type
OG000	6 months change in Comprehensive health state	Fisher's non-parametric permutation test		0.088	2-Sided	95	Superiority or Other
OG000	6 months change in Vision	Fisher's non-parametric permutation test		0.88	2-Sided	95	Superiority or Other
OG000	6 months change in Hearing	Fisher's non-parametric permutation test		0.020	2-Sided	95	Superiority or Other
OG000	6 months change in Speech	Fisher's non-parametric permutation test		0.039	2-Sided	95	Superiority or Other
OG000	6 months change in Ambulation	Fisher's non-parametric permutation test		0.25	2-Sided	95	Superiority or Other
OG000	6 months change in Dexterity	Fisher's non-parametric permutation test		0.38	2-Sided	95	Superiority or Other
OG000	6 months change in Emotion	Fisher's non-parametric permutation test		0.43	2-Sided	95	Superiority or Other
OG000	6 months change in Cognition	Fisher's non-parametric permutation test		0.85	2-Sided	95	Superiority or Other
OG000	6 months change in Pain	Fisher's non-parametric permutation test		0.25	2-Sided	95	Superiority or Other
OG000	24 months change in Comprehensive health state	Fisher's non-parametric permutation test		0.088	2-Sided	95	Superiority or Other
OG000	24 months change in Vision	Fisher's non-parametric permutation test		0.63			Superiority or Other
OG000	24 months change in Hearing	Fisher's non-parametric permutation test		0.045	2-Sided	95	Superiority or Other
OG000	24 months change in Speech	Fisher's non-parametric permutation test		0.016			Superiority or Other
OG000	24 months change in Ambulation	Fisher's non-parametric permutation test		0.25			Superiority or Other
OG000	24 months change in Dexterity	Wilcoxan Signed Rank Test	Fisher's non-parametric permutation test failed to approximate p value so Wilcoxan Signed Rank Test instead	0.50			Superiority or Other
OG000	24 months change in Emotion	Fisher's non-parametric permutation test		0.29			Superiority or Other
OG000	24 months change in Cognition	Fisher's non-parametric permutation test		0.92			Superiority or Other
OG000	24 months change in Pain	Fisher's non-parametric permutation test		0.020			Superiority or Other

Title

Denominators

Categories

6 months: Ease of communication

- ParticipantsOG00053

Title	Measurements
	OG00020.4± 24.9

6 months: Background noise

- ParticipantsOG00053

Title	Measurements
	OG00026.3± 20.6

6 months: Reverberation

- ParticipantsOG00053

Title	Measurements
	OG00022.0± 19.0

6 months: Aversiveness

- ParticipantsOG00053

Title	Measurements
	OG0001.32± 23.45

6 months: Global

- ParticipantsOG00053

Title	Measurements
	OG00022.9± 18.1

24 months: Ease of communication

- ParticipantsOG00045

Title	Measurements
	OG00018.7± 26.3

24 months: Background noise

- ParticipantsOG00045

Title	Measurements
	OG00023.7± 20.4

24 months: Reverberation

- ParticipantsOG00045

Title	Measurements
	OG00020.8± 19.9

24 months: Aversiveness

- ParticipantsOG00045

Title	Measurements
	OG000-0.596± 19.646

24 months: Global

- ParticipantsOG00045

Title	Measurements
	OG00021.1± 18.9

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Confidence Interval Sides	Confidence Interval %	Non-Inferiority Type
OG000	6 months: Ease of communication	Fisher's non-parametric permutation test	<0.0001		2-Sided	95	Superiority or Other
OG000	6 months: Background noise	Fisher's non-parametric permutation test	<0.0001		2-Sided	95	Superiority or Other
OG000	6 months: Reverberation	Fisher's non-parametric permutation test	<0.0001				Superiority or Other
OG000	6 months: Aversiveness	Fisher's non-parametric permutation test	0.69				Superiority or Other
OG000	6 months: Global	Fisher's non-parametric permutation test	<0.0001				Superiority or Other
OG000	24 months: Ease of communication	Fisher's non-parametric permutation test	<0.001				Superiority or Other
OG000	24 months: Background noise	Fisher's non-parametric permutation test	<0.001				Superiority or Other
OG000	24 months: Reverberation	Fisher's non-parametric permutation test	<0.001				Superiority or Other
OG000	24 months: Aversiveness	Fisher's non-parametric permutation test	0.84				Superiority or Other
OG000	24 months: Global	Fisher's non-parametric permutation test	<0.001	Fisher's non-parametric permutation test			Superiority or Other

Title

Denominators

Categories

Speech: Change from pre-op to 6 months

- ParticipantsOG00053

Title	Measurements
	OG0002.49± 1.67

Spatial: Change from pre-op to 6 months

- ParticipantsOG00053

Title	Measurements
	OG0001.87± 1.90

Qualities: Change from pre-op to 6 months

- ParticipantsOG00053

Title	Measurements
	OG0001.68± 1.36

Speech: Change from pre-op to 24 months

- ParticipantsOG00046

Title	Measurements
	OG0002.07± 1.57

Spatial: Change from pre-op to 24 months

- ParticipantsOG00046

Title	Measurements
	OG0001.36± 1.74

Qualities: Change from pre-op to 24 months

- ParticipantsOG00046

Title	Measurements
	OG0001.30± 1.39

Group IDs	Group Description	Statistical Method	P-Value	Confidence Interval Sides	Confidence Interval %	Non-Inferiority Type
OG000	Speech: Change from pre-op to 6 months	Fisher's non-parametric permutation test	<0.0001	2-Sided	95	Superiority or Other
OG000	Spatial: Change from pre-op to 6 months	Fisher's non-parametric permutation test	<0.0001			Superiority or Other
OG000	Qualities: Change from pre-op to 6 months	Fisher's non-parametric permutation test	<0.0001			Superiority or Other
OG000	Speech: Change from pre-op to 24 months	Fisher's non-parametric permutation test	<0.0001			Superiority or Other
OG000	Spatial: Change from pre-op to 24 months	Fisher's non-parametric permutation test	<0.0001			Superiority or Other
OG000	Qualities: Change from pre-op to 24 months	Fisher's non-parametric permutation test	<0.0001			Superiority or Other

Title

Denominators

Categories

4 weeks

- ParticipantsOG00054

Title	Measurements
	OG0001.01± 0.40

6 weeks

- ParticipantsOG00053

Title	Measurements
	OG0001.07± 0.33

12 weeks

- ParticipantsOG00053

Title	Measurements
	OG0001.15± 0.41

6 months

- ParticipantsOG00053

Title	Measurements
	OG0001.16± 0.42

12 months

- ParticipantsOG00052

Title	Measurements
	OG0001.15± 0.38

24 months

- ParticipantsOG00047

Title	Measurements
	OG0001.09± 0.41

Title

Denominators

Categories

Week 4

- ParticipantsOG00054

Title	Measurements
SPM 6	OG00019
SPM 5	OG00019
SPM 4	OG0009
SPM 3	OG0006
SPM 2	OG0001
SPM 1	OG0000

Week 6

- ParticipantsOG00053

Title	Measurements
SPM 6	OG00011
SPM 5	OG00010
SPM 4

Week 12

- ParticipantsOG00053

Title	Measurements
SPM 6	OG0006
SPM 5	OG00012
SPM 4

Month 6

- ParticipantsOG00053

Title	Measurements
SPM 6	OG0005
SPM 5	OG0009
SPM 4

Month 12

- ParticipantsOG00052

Title	Measurements
SPM 6	OG0006
SPM 5	OG00011
SPM 4

Month 24

- ParticipantsOG00046

Title	Measurements
SPM 6	OG0005
SPM 5	OG0008
SPM 4

Title

Denominators

Categories

Week 6

- ParticipantsOG00053

Title	Measurements
No Discomfort or Pain	OG00021
Slight Discomfort or Pain	OG00015
Discomfort or Pain	OG00015
Excessive Discomfort or Pain	OG0002

Week 12

- ParticipantsOG00053

Title	Measurements
No Discomfort or Pain	OG00024
Slight Discomfort or Pain	OG00016
Discomfort or Pain

Month 6

- ParticipantsOG00053

Title	Measurements
No Discomfort or Pain	OG00033
Slight Discomfort or Pain	OG00015
Discomfort or Pain

Month 12

- ParticipantsOG00052

Title	Measurements
No Discomfort or Pain	OG00037
Slight Discomfort or Pain	OG00011
Discomfort or Pain

Month 24

- ParticipantsOG00047

Title	Measurements
No Discomfort or Pain	OG00040
Slight Discomfort or Pain	OG0004
Discomfort or Pain

Title

Denominators

Categories

Day 10: Numbness tested with a Pin

- ParticipantsOG00054

Title	Measurements
No Numbness	OG00012
Numbness within 2cm of Implant	OG0009
Numbness within & beyond 2cm from Implant	OG00033

Week 4: Numbness tested with a pin

- ParticipantsOG00054

Title	Measurements
No Numbness	OG00015
Numbness within 2cm of Implant	OG0007
Numbness within & beyond 2cm from Implant

Week 6: Numbness tested with a pin

- ParticipantsOG00053

Title	Measurements
No Numbness	OG00021
Numbness within 2cm of Implant	OG0003
Numbness within & beyond 2cm from Implant

Week 12: Numbness tested with a pin

- ParticipantsOG00053

Title	Measurements
No Numbness	OG00033
Numbness within 2cm of Implant	OG0005
Numbness within & beyond 2cm from Implant

Month 6: Numbness tested with a Pin

- ParticipantsOG00052

Title	Measurements
No Numbness	OG00042
Numbness within 2cm of Implant	OG0003
Numbness within & beyond 2cm from Implant

Month 12: Numbness tested with a Pin

- ParticipantsOG00052

Title	Measurements
No Numbness	OG00045
Numbness within 2cm of Implant	OG0003
Numbness within & beyond 2cm from Implant

Month 24: Numbness tested with a Pin

- ParticipantsOG00046

Title	Measurements
No Numbness	OG00045
Numbness within 2cm of Implant	OG0000
Numbness within & beyond 2cm from Implant

Title

Denominators

Categories

Day 10: Numbness tested with a Cotton Swab

- ParticipantsOG00054

Title	Measurements
No Numbness	OG00013
Numbness within 2 cm from implant	OG0009
Numbness within & beyond 2cm from Implant	OG00032

Week 4: Numbness tested with a Cotton Swab

- ParticipantsOG00054

Title	Measurements
No Numbness	OG00018
Numbness within 2 cm from implant	OG0006
Numbness within & beyond 2cm from Implant

Week 6: Numbness tested with a Cotton Swab

- ParticipantsOG00053

Title	Measurements
No Numbness	OG00023
Numbness within 2 cm from implant	OG0002
Numbness within & beyond 2cm from Implant

Week 12: Numbness tested with a Cotton Swab

- ParticipantsOG00053

Title	Measurements
No Numbness	OG00031
Numbness within 2 cm from implant	OG0006
Numbness within & beyond 2cm from Implant

Month 6: Numbness tested with a Cotton Swab

- ParticipantsOG00052

Title	Measurements
No Numbness	OG00043
Numbness within 2 cm from implant	OG0002
Numbness within & beyond 2cm from Implant

Month 12: Numbness tested with a Cotton Swab

- ParticipantsOG00052

Title	Measurements
No Numbness	OG00044
Numbness within 2 cm from implant	OG0003
Numbness within & beyond 2cm from Implant

Month 24: Numbness tested with a Cotton Swab

- ParticipantsOG00046

Title	Measurements
No Numbness	OG00042
Numbness within 2 cm from implant	OG0003
Numbness within & beyond 2cm from Implant

ID	Term
D003638	Deafness
D034381	Hearing Loss
D006314	Hearing Loss, Conductive