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| Name | Class |
|---|---|
| Statistiska Konsultgruppen | OTHER |
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The aim of this clinical investigation is to collect data on objective and subjective hearing performance, quality of life and safety in adult subjects with conductive hearing loss, mixed hearing loss or single-sided sensorineural deafness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Osia 2 system | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osia 2 system | Device | System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Condition Assessed Via Audiometric Thresholds | Free field (Pure Tone Average 4, mean of 0.5, 1,2 and 4 kHz) | Baseline before surgery, 3 months after surgery |
| Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Situation Assessed Via Adaptive Speech Recognition in Noise | Speech-to-noise ratio, 50% speech understanding | Baseline before surgery, 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hearing Performance With the Osia 2 System at 4 Weeks and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | Free field (Pure Tone Average 4, mean of 0.5, 1,2 and 4 kHz) | Baseline before surgery, 4 weeks and 6 months after surgery |
| Change in Hearing Performance With the Osia 2 System at 4 Weeks and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Adaptive Speech Recognition in Noise |
Not provided
Inclusion Criteria:
OR Subject with single-sided sensorineural deafness who is a candidate for Baha surgery. Air conduction thresholds with a pure tone average PTA4 (mean of 0.5, 1, 2 and 3 kHz) of ≤ 20 dB sensorineural hearing loss in the good ear OR subject who is indicated for an (Air Conduction-Contralateral Routing of Signal (AC CROS) but-for some reason-cannot or will not use an AC CROS.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karin Ganlöv | Cochlear | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sydney Cochlear Implant Centre | Gladesville | Australia | ||||
| The Royal Victorian Eye and Ear Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37552281 | Derived | Cowan R, Lewis AT, Hallberg C, Tong MCF, Birman CS, Ng IH, Briggs R. Clinical performance, safety, and patient-reported outcomes of an active osseointegrated bone-conduction hearing implant system at 24-month follow-up. Eur Arch Otorhinolaryngol. 2024 Feb;281(2):683-691. doi: 10.1007/s00405-023-08133-3. Epub 2023 Aug 8. | |
| 35878640 |
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29 participants were recruited in three centres from 16 August 2019 to 24 September 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | Osia 2 System | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Osia 2 System | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Condition Assessed Via Audiometric Thresholds | Free field (Pure Tone Average 4, mean of 0.5, 1,2 and 4 kHz) | Data was only received for 27 participants. One participant did not receive the sound processor due to the Covid-19 pandemic and one participant did not attend neither the 4 weeks visit nor the 3 months visit. | Posted | Mean | Standard Deviation | db HL (decibel Hearing Level) | Baseline before surgery, 3 months after surgery |
|
6 months
Adverse events are presented by the CTCAE term.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Osia 2 System | Osia 2 system: System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | CTCAE 4.03 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear and labyrinth disorders - Other | Ear and labyrinth disorders | CTCAE 4.03 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Johan Blechert | Cochlear | +46766498632 | jblechert@cochlear.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 8, 2019 | Jun 15, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 26, 2020 | Jun 15, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006314 | Hearing Loss, Conductive |
| D046089 | Hearing Loss, Mixed Conductive-Sensorineural |
| D003638 | Deafness |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
Not provided
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Speech-to-noise ratio, 50% speech understanding |
| Baseline before surgery, 4 weeks and 6 months after surgery |
| Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | Free-field [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz] | Baseline before surgery, 4 weeks, 3 months and 6 months after surgery |
| Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Speech Recognition in Quiet | % correctly perceived words at 50dB, 65dB and 80dB SPL | Baseline before surgery, 4 weeks, 3 months and 6 months after surgery |
| Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire | Measuring change of Ease of communication, Reverberation, Background noise, Aversiveness and a Global score with the Osia 2 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 impairment, a negative value an improvement. | Baseline before surgery, 3 months and 6 months after surgery |
| Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Speech, Spatial and Qualities of Hearing Scale (SSQ) Questionnaire | Measuring change of speech, spatial and hearing experiences with the Osia 2 System from the pe-operative unaided situation. A scale from 0 to 10 is used, 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. | Baseline before surgery, 3 months and 6 months after surgery |
| Change in Health-related Quality of Life With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Health Utilities Index Mark III (HUI) Questionnaire | Change of health status and health related quality of life using the generic quality of life scale Health Utilities Index (HUI3) when wearing Osia 2 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. | Baseline before surgery, 3 months and 6 months after surgery |
| Surgical Information: Soft Tissue Thickness | Measured in mm | Baseline before surgery or at surgery |
| Surgical Information: Surgery Time | Time in minutes between first incision to last suture | At surgery |
| Surgical Information: Bone Polishing/Removal at the Actuator Site | Yes/No | At surgery |
| Surgical Information: BI300 Implant Length | 3 mm/4 mm | At surgery |
| Surgical Information: Location of BI300 Implant | Measured in mm between the ear canal and the center of the actuator | At surgery |
| Surgical Information: Type of Anesthesia | General/local | At surgery |
| Surgical Information: Soft Tissue Reduction | Yes/No | At surgery |
| Surgical Information: Surgical Incision Type | Examples: C-shaped/S-shaped/straight | At surgery |
| Surgical Information: Location of the Surgical Incision in Relation to the Actuator | Anterior/posterior | At surgery |
| Surgical Information: Estimated Length of the Surgical Incision | Measured in mm | At surgery |
| Surgical Information: Placement of the Coil | Periosteal pocket (under periosteal)/on top of periosteum/on top of muscle) | At surgery |
| Usability Information: Magnet Choice | Magnet strength ranging from 1 to 4 where 1 is the weakest and 4 the strongest. A magnet allows the external sound processor to be placed in the correct position over the implanted system including an internal magnet. | At 4 weeks, 6 weeks, 3 months and 6 months after surgery |
| Usability Information: Sound Processor Retention | Assessed via a Visual Analog Scale 100 mm where 0 mm represents insufficient retention and 100 mm excellent retention | At 4 weeks, 6 weeks, 3 months and 6 months after surgery |
| Usability Information: Sound Processor Wearing Comfort | Assessed via a Visual Analog Scale 100 mm where 0 mm represents no comfort at all and 100 mm excellent comfort | At 4 weeks, 6 weeks, 3 months and 6 months after surgery |
| Usability Information: Use of SoftWear Pad | Yes/No | At 6 weeks, 3 months and 6 months after surgery |
| Usability Information: Daily Use of Sound Processor | Average hours of daily use | At 6 weeks, 3 months and 6 months after surgery |
| Usability Information: Daily Streaming Time of Sound Processor | Average hours of daily streaming | At 6 weeks, 3 months and 6 months after surgery |
| Usability Information: Battery Lifetime of Sound Processor | Average hours of battery lifetime | At 6 weeks, 3 months and 6 months after surgery |
| Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | Free-field [Pure Tone Average (PTA) 4, Mean of 0.5, 1, 2 and 4 kHz]. | Baseline before surgery, 4 weeks, 3 months and 6 months after surgery |
| Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | Free-field [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz]. | Baseline before surgery, 4 weeks, 3 months and 6 months after surgery |
| Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Adaptive Speech Recognition in Noise | Signal-to-noise ratio, 50% speech understanding | Baseline before surgery, 4 weeks, 3 months and 6 months after surgery |
| Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Speech Recognition in Quiet | % correctly perceived words at 50dB, 65dB and 80dB SPL | Baseline before surgery, 4 weeks, 3 months and 6 months after surgery |
| Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC direct (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0 and 6.0 kHz) | Baseline before surgery, 4 weeks, 3 months and 6 months after surgery |
| Melbourne |
| Australia |
| Department of Otorhinolaryngology, Head and Neck Surgery Faculty of Medicine. The Chinese University of Hong Kong | Hong Kong | Hong Kong |
| Briggs R, Birman CS, Baulderstone N, Lewis AT, Ng IHY, Ostblom A, Rousset A, Tari S, Tong MCF, Cowan R. Clinical Performance, Safety, and Patient-Reported Outcomes of an Active Osseointegrated Steady-State Implant System. Otol Neurotol. 2022 Aug 1;43(7):827-834. doi: 10.1097/MAO.0000000000003590. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Situation Assessed Via Adaptive Speech Recognition in Noise | Speech-to-noise ratio, 50% speech understanding | Data was only received for 27 participants. One participant did not receive the sound processor due to the Covid-19 pandemic and one participant did not attend neither the 4 weeks visit nor the 3 months visit. | Posted | Mean | Standard Deviation | db SNR (decibel Speech in Noise Ratio) | Baseline before surgery, 3 months after surgery |
|
|
|
| Secondary | Change in Hearing Performance With the Osia 2 System at 4 Weeks and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | Free field (Pure Tone Average 4, mean of 0.5, 1,2 and 4 kHz) | At 4 weeks, data was only received for 27 participants. One participant did not receive the sound processor due to the Covid-19 pandemic and one participant did not attend neither the 4 weeks visit nor the 3 months visit. At 6 months visit, data was received for 28 participants.The participant that did not attend previous visits did visit the site and data was collected. The participant that did not receive the sound processor still could not visit site. | Posted | Mean | Standard Deviation | db HL (decibel Hearing Level) | Baseline before surgery, 4 weeks and 6 months after surgery |
|
|
|
| Secondary | Change in Hearing Performance With the Osia 2 System at 4 Weeks and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Adaptive Speech Recognition in Noise | Speech-to-noise ratio, 50% speech understanding | At 4 weeks, data was only received for 27 participants. One participant did not receive the sound processor due to the Covid-19 pandemic and one participant did not attend neither the 4 weeks visit nor the 3 months visit. At 6 months visit, data was received for 28 participants.The participant that did not attend previous visits did visit the site and data was collected. The participant that did not receive the sound processor still could not visit site. | Posted | Mean | Standard Deviation | db SNR (decibel Speech in Noise Ratio) | Baseline before surgery, 4 weeks and 6 months after surgery |
|
|
|
| Secondary | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Audiometric Thresholds | Free-field [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz] | At the 4 weeks and 3 months visits, data was only received for 27 participants. One participant did not receive the sound processor due to the Covid-19 pandemic and one participant did not attend neither the 4 weeks visit nor the 3 months visit. At the 6 months visit, data was received for 28 participants. The participant that did not attend previous visits did visit the site and data was collected. The participant that did not receive the sound processor still could not visit site. | Posted | Mean | Standard Deviation | db HL (decibel Hearing Level) | Baseline before surgery, 4 weeks, 3 months and 6 months after surgery |
|
|
|
| Secondary | Change in Hearing Performance With the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Compared to Preoperative Unaided Situation Assessed Via Speech Recognition in Quiet | % correctly perceived words at 50dB, 65dB and 80dB SPL | At the 4 weeks and 3 months visits, data was only received for 27 participants. One participant did not receive the sound processor due to the Covid-19 pandemic and one participant did not attend neither the 4 weeks visit nor the 3 months visit. At the 6 months visit, data was received for 28 participants. The participant that did not attend previous visits did visit the site and data was collected. The participant that did not receive the sound processor still could not visit site. | Posted | Mean | Standard Deviation | Percentage of correct words | Baseline before surgery, 4 weeks, 3 months and 6 months after surgery |
|
|
|
| Secondary | Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire | Measuring change of Ease of communication, Reverberation, Background noise, Aversiveness and a Global score with the Osia 2 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 impairment, a negative value an improvement. | One participant did not receive the sound processor and did not perform this questionnaire at either 3- or 6-months visit. One participant did not perform this questionnaire at 3-month visit and another participant did not perform this questionnaire at the 6-month visit. | Posted | Mean | Standard Deviation | units on a scale | Baseline before surgery, 3 months and 6 months after surgery |
|
|
|
| Secondary | Change in Self-reported Hearing Outcome With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Speech, Spatial and Qualities of Hearing Scale (SSQ) Questionnaire | Measuring change of speech, spatial and hearing experiences with the Osia 2 System from the pe-operative unaided situation. A scale from 0 to 10 is used, 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. | One participant did not receive the sound processor and did not perform this questionnaire at either 3- or 6-months visit. One participant did not perform this questionnaire at 3-month visit and another participant did not perform this questionnaire at the 6-month visit. | Posted | Mean | Standard Deviation | Score on a scale | Baseline before surgery, 3 months and 6 months after surgery |
|
|
|
| Secondary | Change in Health-related Quality of Life With the Osia 2 System at 3 Months and 6 Months Post Surgery Compared to the Preoperative Unaided Situation Via the Health Utilities Index Mark III (HUI) Questionnaire | Change of health status and health related quality of life using the generic quality of life scale Health Utilities Index (HUI3) when wearing Osia 2 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. | One participant did not receive the sound processor and did not perform this questionnaire at either 3- or 6-months visit. One participant did not perform this questionnaire at 3-month visit and another participant did not perform this questionnaire at the 6-month visit. | Posted | Mean | Standard Deviation | score on a scale | Baseline before surgery, 3 months and 6 months after surgery |
|
|
|
| Secondary | Surgical Information: Soft Tissue Thickness | Measured in mm | Posted | Mean | Standard Deviation | mm | Baseline before surgery or at surgery |
|
|
|
| Secondary | Surgical Information: Surgery Time | Time in minutes between first incision to last suture | Surgery time was not measured for one of the participants. | Posted | Mean | Standard Deviation | min | At surgery |
|
|
|
| Secondary | Surgical Information: Bone Polishing/Removal at the Actuator Site | Yes/No | Posted | Count of Participants | Participants | At surgery |
|
|
|
| Secondary | Surgical Information: BI300 Implant Length | 3 mm/4 mm | Posted | Count of Participants | Participants | At surgery |
|
|
|
| Secondary | Surgical Information: Location of BI300 Implant | Measured in mm between the ear canal and the center of the actuator | Data only gathered for 26 participants. | Posted | Mean | Standard Deviation | mm | At surgery |
|
|
|
| Secondary | Surgical Information: Type of Anesthesia | General/local | Posted | Count of Participants | Participants | At surgery |
|
|
|
| Secondary | Surgical Information: Soft Tissue Reduction | Yes/No | Posted | Count of Participants | Participants | At surgery |
|
|
|
| Secondary | Surgical Information: Surgical Incision Type | Examples: C-shaped/S-shaped/straight | Posted | Count of Participants | Participants | At surgery |
|
|
|
| Secondary | Surgical Information: Location of the Surgical Incision in Relation to the Actuator | Anterior/posterior | Posted | Count of Participants | Participants | At surgery |
|
|
|
| Secondary | Surgical Information: Estimated Length of the Surgical Incision | Measured in mm | Posted | Mean | Standard Deviation | mm | At surgery |
|
|
|
| Secondary | Surgical Information: Placement of the Coil | Periosteal pocket (under periosteal)/on top of periosteum/on top of muscle) | Posted | Count of Participants | Participants | At surgery |
|
|
|
| Secondary | Usability Information: Magnet Choice | Magnet strength ranging from 1 to 4 where 1 is the weakest and 4 the strongest. A magnet allows the external sound processor to be placed in the correct position over the implanted system including an internal magnet. | For some participants the data are not available at all visits. | Posted | Count of Participants | Participants | At 4 weeks, 6 weeks, 3 months and 6 months after surgery |
|
|
|
| Secondary | Usability Information: Sound Processor Retention | Assessed via a Visual Analog Scale 100 mm where 0 mm represents insufficient retention and 100 mm excellent retention | Some participants did not perform the test at all visits. | Posted | Mean | Standard Deviation | units on a scale | At 4 weeks, 6 weeks, 3 months and 6 months after surgery |
|
|
|
| Secondary | Usability Information: Sound Processor Wearing Comfort | Assessed via a Visual Analog Scale 100 mm where 0 mm represents no comfort at all and 100 mm excellent comfort | Some participants did not perform the test at all visits. | Posted | Mean | Standard Deviation | units on a scale | At 4 weeks, 6 weeks, 3 months and 6 months after surgery |
|
|
|
| Secondary | Usability Information: Use of SoftWear Pad | Yes/No | For some participants the data are not available at all visits. | Posted | Count of Participants | Participants | At 6 weeks, 3 months and 6 months after surgery |
|
|
|
| Secondary | Usability Information: Daily Use of Sound Processor | Average hours of daily use | For some participants the data are not available at all visits. | Posted | Mean | Standard Deviation | hours/day | At 6 weeks, 3 months and 6 months after surgery |
|
|
|
| Secondary | Usability Information: Daily Streaming Time of Sound Processor | Average hours of daily streaming | For some participants the data are not available at all visits. | Posted | Mean | Standard Deviation | hours/day | At 6 weeks, 3 months and 6 months after surgery |
|
|
|
| Secondary | Usability Information: Battery Lifetime of Sound Processor | Average hours of battery lifetime | For some participants the data are not available at all visits. | Posted | Mean | Standard Deviation | hours | At 6 weeks, 3 months and 6 months after surgery |
|
|
|
| Secondary | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | Free-field [Pure Tone Average (PTA) 4, Mean of 0.5, 1, 2 and 4 kHz]. | Some participants did not perform the test at all visits. | Posted | Mean | Standard Deviation | db HL (decibel Hearing Level) | Baseline before surgery, 4 weeks, 3 months and 6 months after surgery |
|
|
|
| Secondary | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Audiometric Thresholds | Free-field [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz]. | Some participants did not perform the test at all visits. | Posted | Mean | Standard Deviation | db HL (decibel Hearing Level) | Baseline before surgery, 4 weeks, 3 months and 6 months after surgery |
|
|
|
| Secondary | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Adaptive Speech Recognition in Noise | Signal-to-noise ratio, 50% speech understanding | Some participants did not perform the test at all visits. | Posted | Mean | Standard Deviation | db SNR (decibel Speech in Noise Ratio) | Baseline before surgery, 4 weeks, 3 months and 6 months after surgery |
|
|
|
| Secondary | Difference in Hearing Performance Between the Osia 2 System and a Baha 5 Power Sound Processor on a Baha Softband (Preoperative) at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Speech Recognition in Quiet | % correctly perceived words at 50dB, 65dB and 80dB SPL | Some participants did not perform all tests at all visits. | Posted | Mean | Standard Deviation | Percentage of correct words | Baseline before surgery, 4 weeks, 3 months and 6 months after surgery |
|
|
|
| Secondary | Hearing Performance Using a Baha Softband (Preoperative) at Baseline and the Osia 2 System at 4 Weeks, 3 Months and 6 Months Post Surgery Assessed Via Bone Conduction (BC) Direct | BC direct (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0 and 6.0 kHz) | Some participants did not perform the test at all visits. | Posted | Mean | Standard Deviation | db HL (decibel Hearing Level) | Baseline before surgery, 4 weeks, 3 months and 6 months after surgery |
|
|
|
| 0 |
| 29 |
| 3 |
| 29 |
| 21 |
| 29 |
| Infected Skin/ Wound With Subcutaneous Collection | Infections and infestations | CTCAE 4.03 | Non-systematic Assessment |
|
| Infected Wound/Possible Flap Compromise | Infections and infestations | CTCAE 4.03 | Non-systematic Assessment |
|
| Preoperative Bradycardia | Cardiac disorders | CTCAE 4.03 | Non-systematic Assessment |
|
| General disorders and administration site conditions - Other | General disorders | CTCAE 4.03 | Non-systematic Assessment |
|
| Wound infection | Infections and infestations | CTCAE 4.03 | Non-systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | CTCAE 4.03 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE 4.03 | Non-systematic Assessment |
|
| Psychiatric Disorders - Other | Psychiatric disorders | CTCAE 4.03 | Non-systematic Assessment |
|
The institutions agree that no publication of the study results may be made until publication of the results of the multi-centre study or 2 years after study completion, whichever is the sooner.
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
|
|
| 0.75 kHz, 4 weeks |
|
|
| 1.0 kHz, 4 weeks |
|
|
| 1.5 kHz, 4 weeks |
|
|
| 2.0 kHz, 4 weeks |
|
|
| 3.0 kHz, 4 weeks |
|
|
| 4.0 kHz, 4 weeks |
|
|
| 6.0 kHz, 4 weeks |
|
|
| 8.0 kHz, 4 weeks |
|
|
| 0.25 kHz, 3 months |
|
|
| 0.5 kHz, 3 months |
|
|
| 0.75 kHz, 3 months |
|
|
| 1.0 kHz, 3 months |
|
|
| 1.5 kHz, 3 months |
|
|
| 2.0 kHz, 3 months |
|
|
| 3.0 kHz, 3 months |
|
|
| 4.0 kHz, 3 months |
|
|
| 6.0 kHz, 3 months |
|
|
| 8.0 kHz, 3 months |
|
|
| 0.25 kHz, 6 months |
|
|
| 0.5 kHz, 6 months |
|
|
| 0.75 kHz, 6 months |
|
|
| 1.0 kHz, 6 months |
|
|
| 1.5 kHz, 6 months |
|
|
| 2.0 kHz, 6 months |
|
|
| 3.0 kHz, 6 months |
|
|
| 4.0 kHz, 6 months |
|
|
| 6.0 kHz, 6 months |
|
|
| 8.0 kHz, 6 months |
|
|
|
| Speech in quiet at 80 dB, 4 weeks |
|
|
| Speech in quiet at 50 dB, 3 months |
|
|
| Speech in quiet at 65 dB, 3 months |
|
|
| Speech in quiet at 80 dB, 3 months |
|
|
| Speech in quiet at 50 dB, 6 months |
|
|
| Speech in quiet at 65 dB, 6 months |
|
|
| Speech in quiet at 80 dB, 6 months |
|
|
|
| APHAB - Aversiveness, 3 months |
|
| APHAB - Global, 3 months |
|
| APHAB - Ease of communication, 6 months |
|
| APHAB - Background Noise, 6 months |
|
| APHAB - Reverberation, 6 months |
|
| APHAB - Aversiveness, 6 months |
|
| APHAB - Global, 6 months |
|
| Title | Measurements |
|---|---|
|
| SSQ12 Quality score, 3 months |
|
| SSQ12 Total score, 6 months |
|
| SSQ12 Speech score, 6 months |
|
| SSQ12 Spatial score, 6 months |
|
| SSQ12 Quality score, 6 months |
|
|
| Speech attribute, 3 months |
|
| Ambulation attribute, 3 months |
|
| Dexterity attribute, 3 months |
|
| Emotion attribute, 3 months |
|
| Cognition attribute, 3 months |
|
| Pain attribute (HUI3), 3 months |
|
| Comprehensive Health State, 6 months |
|
| Vision attribute, 6 months |
|
| Hearing attribute, 6 months |
|
| Speech attribute, 6 months |
|
| Ambulation attribute, 6 months |
|
| Dexterity attribute, 6 months |
|
| Emotion attribute, 6 months |
|
| Cognition attribute, 6 months |
|
| Pain attribute (HUI3), 6 months |
|
| Straight |
|
|
|
| Magnet strength 4, 4 weeks |
|
|
| Magnet strength 2, 6 weeks |
|
|
| Magnet strength 3, 6 weeks |
|
|
| Magnet strength 4, 6 weeks |
|
|
| Magnet strength 2, 3 months |
|
|
| Magnet strength 3, 3 months |
|
|
| Magnet strength 4, 3 months |
|
|
| Magnet strength 2, 6 months |
|
|
| Magnet strength 3, 6 months |
|
|
| Magnet strength 4, 6 months |
|
|
|
| Overall Retention, 3 months |
|
|
| Overall Retention, 6 months |
|
|
|
| Overall Comfort, 3 months |
|
|
| Overall Comfort, 6 months |
|
|
|
| Yes, 3 months |
|
|
| No, 3 months |
|
|
| Yes, 6 months |
|
|
| No, 6 months |
|
|
|
| Daily use, 6 months |
|
|
|
| Streaming, 6 months |
|
|
|
| 6 months |
|
|
|
| PTA4, 6 months |
|
|
|
| 0.75 kHz, 4 weeks |
|
|
| 1.0 kHz, 4 weeks |
|
|
| 1.5 kHz, 4 weeks |
|
|
| 2.0 kHz, 4 weeks |
|
|
| 3.0 kHz, 4 weeks |
|
|
| 4.0 kHz, 4 weeks |
|
|
| 6.0 kHz, 4 weeks |
|
|
| 8.0 kHz, 4 weeks |
|
|
| 0.25 kHz, 3 months |
|
|
| 0.5 kHz, 3 months |
|
|
| 0.75 kHz, 3 months |
|
|
| 1.0 kHz, 3 months |
|
|
| 1.5 kHz, 3 months |
|
|
| 2.0 kHz, 3 months |
|
|
| 3.0 kHz, 3 months |
|
|
| 4.0 kHz, 3 months |
|
|
| 6.0 kHz, 3 months |
|
|
| 8.0 kHz, 3 months |
|
|
| 0.25 kHz, 6 months |
|
|
| 0.5 kHz, 6 months |
|
|
| 0.75 kHz, 6 months |
|
|
| 1.0 kHz, 6 months |
|
|
| 1.5 kHz, 6 months |
|
|
| 2.0 kHz, 6 months |
|
|
| 3.0 kHz, 6 months |
|
|
| 4.0 kHz, 6 months |
|
|
| 6.0 kHz, 6 months |
|
|
| 8.0 kHz, 6 months |
|
|
|
| 6 months |
|
|
|
| Speech in quiet at 80 dB, 4 weeks |
|
|
| Speech in quiet at 50 dB, 3 months |
|
|
| Speech in quiet at 65 dB, 3 months |
|
|
| Speech in quiet at 80 dB, 3 months |
|
|
| Speech in quiet at 50 dB, 6 months |
|
|
| Speech in quiet at 65 dB, 6 months |
|
|
| Speech in quiet at 80 dB, 6 months |
|
|
|
| BC Direct 750 Hz, baseline |
|
|
| BC Direct 1000 Hz, baseline |
|
|
| BC Direct 1500 Hz, baseline |
|
|
| BC Direct 2000 Hz, baseline |
|
|
| BC Direct 3000 Hz, baseline |
|
|
| BC Direct 4000 Hz, baseline |
|
|
| BC Direct 6000 Hz, baseline |
|
|
| BC Direct 250 Hz, 4 weeks |
|
|
| BC Direct 500 Hz, 4 weeks |
|
|
| BC Direct 750 Hz, 4 weeks |
|
|
| BC Direct 1000 Hz, 4 weeks |
|
|
| BC Direct 1500 Hz, 4 weeks |
|
|
| BC Direct 2000 Hz, 4 weeks |
|
|
| BC Direct 3000 Hz, 4 weeks |
|
|
| BC Direct 4000 Hz, 4 weeks |
|
|
| BC Direct 6000 Hz, 4 weeks |
|
|
| BC Direct 250 Hz, 3 months |
|
|
| BC Direct 500 Hz, 3 months |
|
|
| BC Direct 750 Hz, 3 months |
|
|
| BC Direct 1000 Hz, 3 months |
|
|
| BC Direct 1500 Hz, 3 months |
|
|
| BC Direct 2000 Hz, 3 months |
|
|
| BC Direct 3000 Hz, 3 months |
|
|
| BC Direct 4000 Hz, 3 months |
|
|
| BC Direct 6000 Hz, 3 months |
|
|
| BC Direct 250 Hz, 6 months |
|
|
| BC Direct 500 Hz, 6 months |
|
|
| BC Direct 750 Hz, 6 months |
|
|
| BC Direct 1000 Hz, 6 months |
|
|
| BC Direct 1500 Hz, 6 months |
|
|
| BC Direct 2000 Hz, 6 months |
|
|
| BC Direct 3000 Hz, 6 months |
|
|
| BC Direct 4000 Hz, 6 months |
|
|
| BC Direct 6000 Hz, 6 months |
|
|