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The study is a combined retrospective (fitting visit) and prospective (study visit), multi-center, single arm study The study is part of the Post Market Clinical Follow (PMCF) activity. The investigational device used in this study is the Ponto 4 already fitted to the subjects prior to the study. The device is CE marked and available on the market since June 2019.
Treatment is not provided in the study therefore risks are limited to the audiological measurements. The audiological measurements in the study are standard non-invasive measurements already familiar to the clinics.
The hearing with Ponto 4 will be evaluated via speech and hearing tests, and patient reported outcomes.
This is a post market clinical follow up (PMCF) study with the purpose of gather knowledge on the use and performance of the Ponto 4 device on existing Ponto 4 users. The study does not include any treatment or fitting of new devices, instead the real-life application of the use of Ponto 4 on subjects already using Ponto 4(s) are investigated.
The Investigational Device used in the study is Ponto 4, a CE marked, and FDA cleared bone anchored hearing solution, produced by Oticon Medical AB and commercially available since June 2019.
The recruitment for this clinical investigation will be performed among subjects who have already received a Ponto 4 device as a minimum 1.5 month prior to the study. 20 patients, including minors down to 12 years old, with a conductive, mixed hearing loss or single-sided deafness will be included. The rationale for including minors is that they are also users of the device, and it is found important to collect data from their experience of using the device as well.
The study is a retrospective and prospective, multi-center study. It has one visit of 2,5-3 hours for adult subjects ≥18 years old. To minimize the burden and risks of tiredness for the minor subjects from 12-17 years old, the protocol activities can be divided into two visits. The decision will be based on the Investigators discretion.
The majority of the objectives of the study are prospectively collected whereas the BC In-situ (hearing with the Ponto 4 on) and audiometric data from the time of the fitting of Ponto 4, are collected retrospectively from the time of the fitting of Ponto 4 (aka the fitting visit).
The overall objectives of the study are to investigate the improvement in hearing with the Ponto 4(s) on the implanted ear(s), in terms of the subject's ability to hear sounds and understand speech when using the device.
The primary endpoint is to investigate the improvement in hearing with the Ponto 4(s) on the implanted ear for patients within intended use.
These will be evaluated through a hearing and a speech test, both assessing the hearing with the Ponto 4(s) both on and off. Additionally, the subject will complete 2 patient reported outcome, report daily usage time of the device and assess satisfaction of connectivity devices.
Minimal risks are expected for subjects participating in the study. Treatment is not provided in the study therefore risks are limited to the audiological measurements. The audiological measurements in the study are standard non-invasive measurements already familiar to the clinics. The measurements will require an extra effort and may be found slightly tiring by the subject. To mitigate the risk of tiredness the subject will be given the opportunity to have breaks during the visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm | Experimental | Asessments for the hearing with Ponto 4 sound processor on the implanted ear(s). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Audiometry | Device | Audiometry: Thresholds from the audiogram obtained when Ponto 4 were fitted. Pure tone air conduction (AC) and bone conduction (BC) audiometry conducted at the visit. Speech recognition in quiet: Speech intelligibility is measured in a soundproof room using the Matrix sentences presented from a loudspeaker. The Matrix test includes five-word sentences with a fixed syntactical structure and limited contextual cues. A list of 20 sentences is compiled from these words, ensuring that no sentence is repeated twice. This test will be obtained both unaided and aided (with and without the Ponto 4(s)). Sound field Audiometry: Detection of sound field thresholds presented from a loudspeaker. Thresholds will be obtained both unaided and aided and the test order will be balanced between subjects. During these measurements, the Ponto 4 will be programmed in omni-directional mode, with noise reduction and feedback management system turned off. |
| Measure | Description | Time Frame |
|---|---|---|
| To Investigate the Improvement in Hearing With the Ponto 4 (s) on the Implanted Ear for Patients Within Intended Use. | Functional gain with Ponto 4, i.e. the difference between average unaided and aided sound field thresholds. The functional gain (PTA4) is calculated as the average of frequencies 500, 1000, 2000 and 4000 Hz. | The outcome measure was assessed during Study Visit 1 (Day 1). |
| Measure | Description | Time Frame |
|---|---|---|
| B. To Assess the Improvement of Hearing With the Ponto 4 on the Implanted Ear(s). | 1. Functional gain with Ponto 4, i.e. the difference between unaided and aided sound field thresholds, for frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz. | The outcome measure was assessed during Study Visit 1 (Day 1). |
| Measure | Description | Time Frame |
|---|---|---|
| L. To Assess the Usage and Performance of Connectivity Device(s) | 1. Questionnaire: Self-reported satisfaction ratings 0-10, for connectivity device(s) previously given to the test subject, where 0 is "very unsatisfied" and 10 is "very satisfied". | Visit 1, Day 1 |
| F. To Assess the Usage Time With Ponto 4. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chris L Jacobsen, MD | Aalborg University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Aalborg | 9000 | Denmark |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ponto 4 Sound Processor Users | Asessments for the hearing with Ponto 4 sound processor on the implanted ear(s). Audiometry: Audiometry: Thresholds from the audiogram obtained when Ponto 4 were fitted. Pure tone air conduction (AC) and bone conduction (BC) audiometry conducted at the visit. Speech recognition in quiet: Speech intelligibility is measured in a soundproof room using the Matrix sentences presented from a loudspeaker. The Matrix test includes five-word sentences with a fixed syntactical structure and limited contextual cues. A list of 20 sentences is compiled from these words, ensuring that no sentence is repeated twice. This test will be obtained both unaided and aided (with and without the Ponto 4(s)). Sound field Audiometry: Detection of sound field thresholds presented from a loudspeaker. Thresholds will be obtained both unaided and aided and the test order will be balanced between subjects. During these measurements, the Ponto 4 will be programmed in omni-directional mode, with noise reduction and feedback management system turned off. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ponto 4 Sound Processor Users | Asessments for the hearing with Ponto 4 sound processor on the implanted ear(s). Audiometry: Audiometry: Thresholds from the audiogram obtained when Ponto 4 were fitted. Pure tone air conduction (AC) and bone conduction (BC) audiometry conducted at the visit. Speech recognition in quiet: Speech intelligibility is measured in a soundproof room using the Matrix sentences presented from a loudspeaker. The Matrix test includes five-word sentences with a fixed syntactical structure and limited contextual cues. A list of 20 sentences is compiled from these words, ensuring that no sentence is repeated twice. This test will be obtained both unaided and aided (with and without the Ponto 4(s)). Sound field Audiometry: Detection of sound field thresholds presented from a loudspeaker. Thresholds will be obtained both unaided and aided and the test order will be balanced between subjects. During these measurements, the Ponto 4 will be programmed in omni-directional mode, with noise reduction and feedback management system turned off. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | To Investigate the Improvement in Hearing With the Ponto 4 (s) on the Implanted Ear for Patients Within Intended Use. | Functional gain with Ponto 4, i.e. the difference between average unaided and aided sound field thresholds. The functional gain (PTA4) is calculated as the average of frequencies 500, 1000, 2000 and 4000 Hz. | only 18 subjects had measurable thresholds for all 4 frequencies to be calculated for the PTA4 of functional gain. | Posted | Mean | Standard Deviation | [dB] | The outcome measure was assessed during Study Visit 1 (Day 1). |
|
study duration was one, approximately 2 hour long, visit.
No adverse events nor device deficiencies were encountered during the study. No serious adverse events were encountered during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ponto 4 Sound Processor Users | Assessments of users with Ponto 4 sound processor on the implanted ear(s). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicole Amichetti, PhD | Oticon Medical | 6093660424 | nitc@oticonmedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 30, 2021 | Nov 28, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006314 | Hearing Loss, Conductive |
| D046089 | Hearing Loss, Mixed Conductive-Sensorineural |
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| ID | Term |
|---|---|
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D001299 | Audiometry |
| D000071066 | Patient Reported Outcome Measures |
| ID | Term |
|---|---|
| D006320 | Hearing Tests |
| D003939 | Diagnostic Techniques, Otological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| C. To Assess the Improvement of Speech Recognition With Ponto 4 on the Implanted Ear(s). |
Difference in speech recognition score in percent between unaided and aided, assessed in quiet. Speech recognition was measured in free field using the Matrix sentences test. The Matrix test includes five-word sentences with a fixed syntactical structure and limited contextual cues. A formula selects a word from a category (name, verb, number, adjective and noun) and creates a five-word sentence. A word from each category is chosen at random to create the sentence. A list of 20 sentences is compiled from these words, ensuring that no sentence is repeated twice. Speech was presented from a loudspeaker 1 meter in front of the subject (0 degree azimuth). The speech signal was fixed at 65 dB SPL (C-weighted). The subject had to repeat as many words as possible after each sentence. For the aided condition, Ponto 4 was tested in the subject's user settings. The test order of aided and unaided condition was balanced across subjects. |
| The outcome measure was assessed during Study Visit 1 (Day 1). |
| G. To Assess the Degree to Which the Ponto 4 Compensates for the BC Hearing Loss on the Implanted Ear(s). | 1. Effective gain defined as the difference in dB between aided sound field thresholds with Ponto 4, and BC In-situ thresholds on the aided ear(s) measured at the time of the fitting of Ponto 4(s). The effective gain is calculated for frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz. | The assessment for this outcome measure was based on the BC in situ test conducted during a visit at least 6 weeks prior to Study Visit 1 (data collected retrospectively), and an aided sound field thresholds test conducted on Study Visit Day 1. |
| H. To Evaluate the Above Objectives on Individual Levels | Endpoints A1, B1, C1 analyzed as the proportion of subjects whose performance improved or remained the same (difference ≥ 0) in unaided to aided comparisons. | The outcome measure was assessed during Study Visit 1 (Day 1). |
| I. To Assess the Degree of Inner Ear Hearing Loss Degradation on the Implanted Ear(s) (for SSD the Stimulated Ear). | 1. Hearing loss degradation is the difference in dB between masked (if not available unmasked) BC thresholds obtained at the study visit, and at the visit when Ponto 4(s) was fitted. Hearing loss degradation for subjects with MHL/CHL is the difference in dB between masked (if not available, then unmasked) BC thresholds obtained at the study visit and at the visit when the Ponto 4(s) was fitted. For subjects with SSD, AC thresholds on the non-implanted ear were used for this calculation. | Fitting Visit (at least 6 weeks prior to Study Visit 1 - data retrospectively collected) and Study Visit 1 (Day 1). |
| J. To Assess if a Patient's With CHL/MHL Hearing Loss Has Degraded to Being Outside Fitting Range on the Implanted Ear(s). | 1. BC hearing loss (PTA4), measured at the study visit, being outside intended fitting range (PTA4 >45 dB HL) compared to being inside fitting range (PTA<45 dB HL) at the time of the study visit. | fitting visit ≥6 weeks prior to study visit |
| K. To Asses if Patients' With CHL/MHL Air to Bone Gap (PTA4) Has Increased/Decreased on the Implanted Ear(s) | 1. The difference between masked (if not available unmasked) BC and AC thresholds, denoted 'air to bone gap', calculated for frequencies 500, 1000, 2000 and 4000 Hz from audiogram measured at the study visit and the fitting visit. | Fitting Visit (at least 6 weeks prior to Study Visit 1 - data retrospectively collected) and Study Visit 1 (Day 1). |
Questionnaire: Self-reported usage hours per day during the month prior to the study visit across all subjects. |
| Visit 1, Day 1 |
| E. To Assess the Quality of Life of the Ponto 4 | GHSI Questionnaire: Scores across all subjects, on a scale from 0 to 100, with a higher score indicating a better quality of life. | Visit 1, Day 1 (For minors: Can be performed at a Visit 2, week 2, +/- 1 week) |
| D. To Assess the Subjective Experience of the Ponto 4 | SSQ Questionnaire: Scores across all subjects, on a subjective scale from 0-10, where 0 is "the worst" and 10 is "the best" | Visit 1,Day 1 (For minors: Can be performed at a Visit 2, week 2, +/- 1 week) |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Secondary | B. To Assess the Improvement of Hearing With the Ponto 4 on the Implanted Ear(s). | 1. Functional gain with Ponto 4, i.e. the difference between unaided and aided sound field thresholds, for frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz. | Posted | Mean | Standard Deviation | [dB] | The outcome measure was assessed during Study Visit 1 (Day 1). |
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| Secondary | C. To Assess the Improvement of Speech Recognition With Ponto 4 on the Implanted Ear(s). | Difference in speech recognition score in percent between unaided and aided, assessed in quiet. Speech recognition was measured in free field using the Matrix sentences test. The Matrix test includes five-word sentences with a fixed syntactical structure and limited contextual cues. A formula selects a word from a category (name, verb, number, adjective and noun) and creates a five-word sentence. A word from each category is chosen at random to create the sentence. A list of 20 sentences is compiled from these words, ensuring that no sentence is repeated twice. Speech was presented from a loudspeaker 1 meter in front of the subject (0 degree azimuth). The speech signal was fixed at 65 dB SPL (C-weighted). The subject had to repeat as many words as possible after each sentence. For the aided condition, Ponto 4 was tested in the subject's user settings. The test order of aided and unaided condition was balanced across subjects. | Posted | Mean | Standard Deviation | percentage points (% points) | The outcome measure was assessed during Study Visit 1 (Day 1). |
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| Secondary | G. To Assess the Degree to Which the Ponto 4 Compensates for the BC Hearing Loss on the Implanted Ear(s). | 1. Effective gain defined as the difference in dB between aided sound field thresholds with Ponto 4, and BC In-situ thresholds on the aided ear(s) measured at the time of the fitting of Ponto 4(s). The effective gain is calculated for frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz. | Ponto 4 Sound Processor Users | Posted | Mean | Standard Deviation | dB | The assessment for this outcome measure was based on the BC in situ test conducted during a visit at least 6 weeks prior to Study Visit 1 (data collected retrospectively), and an aided sound field thresholds test conducted on Study Visit Day 1. |
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| Secondary | H. To Evaluate the Above Objectives on Individual Levels | Endpoints A1, B1, C1 analyzed as the proportion of subjects whose performance improved or remained the same (difference ≥ 0) in unaided to aided comparisons. | Posted | Number | Percentage of participants (%) | The outcome measure was assessed during Study Visit 1 (Day 1). |
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| Secondary | I. To Assess the Degree of Inner Ear Hearing Loss Degradation on the Implanted Ear(s) (for SSD the Stimulated Ear). | 1. Hearing loss degradation is the difference in dB between masked (if not available unmasked) BC thresholds obtained at the study visit, and at the visit when Ponto 4(s) was fitted. Hearing loss degradation for subjects with MHL/CHL is the difference in dB between masked (if not available, then unmasked) BC thresholds obtained at the study visit and at the visit when the Ponto 4(s) was fitted. For subjects with SSD, AC thresholds on the non-implanted ear were used for this calculation. | MHL/CHL - n=11 SSD - n=5 | Posted | Mean | Standard Deviation | dB | Fitting Visit (at least 6 weeks prior to Study Visit 1 - data retrospectively collected) and Study Visit 1 (Day 1). |
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| Secondary | J. To Assess if a Patient's With CHL/MHL Hearing Loss Has Degraded to Being Outside Fitting Range on the Implanted Ear(s). | 1. BC hearing loss (PTA4), measured at the study visit, being outside intended fitting range (PTA4 >45 dB HL) compared to being inside fitting range (PTA<45 dB HL) at the time of the study visit. | Not Posted | Nov 2025 | fitting visit ≥6 weeks prior to study visit | Participants |
| Secondary | K. To Asses if Patients' With CHL/MHL Air to Bone Gap (PTA4) Has Increased/Decreased on the Implanted Ear(s) | 1. The difference between masked (if not available unmasked) BC and AC thresholds, denoted 'air to bone gap', calculated for frequencies 500, 1000, 2000 and 4000 Hz from audiogram measured at the study visit and the fitting visit. | Air to bone gap (PTA4) at fitting and study visit across MHL/CHL subjects. | Posted | Mean | Standard Deviation | dB | Fitting Visit (at least 6 weeks prior to Study Visit 1 - data retrospectively collected) and Study Visit 1 (Day 1). |
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| Other Pre-specified | L. To Assess the Usage and Performance of Connectivity Device(s) | 1. Questionnaire: Self-reported satisfaction ratings 0-10, for connectivity device(s) previously given to the test subject, where 0 is "very unsatisfied" and 10 is "very satisfied". | All participants included. Participants asked to rate their connectivity device(s) used, on a scale of 0.0 (very dissatisfied) to 10.0 (very satisfied). | Posted | Mean | Standard Deviation | units on a scale | Visit 1, Day 1 |
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| Other Pre-specified | F. To Assess the Usage Time With Ponto 4. | Questionnaire: Self-reported usage hours per day during the month prior to the study visit across all subjects. | Posted | Mean | Standard Deviation | average hours/day | Visit 1, Day 1 |
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| Other Pre-specified | E. To Assess the Quality of Life of the Ponto 4 | GHSI Questionnaire: Scores across all subjects, on a scale from 0 to 100, with a higher score indicating a better quality of life. | Posted | Mean | Standard Deviation | units on a scale | Visit 1, Day 1 (For minors: Can be performed at a Visit 2, week 2, +/- 1 week) |
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| Other Pre-specified | D. To Assess the Subjective Experience of the Ponto 4 | SSQ Questionnaire: Scores across all subjects, on a subjective scale from 0-10, where 0 is "the worst" and 10 is "the best" | Posted | Mean | Standard Deviation | units on a scale | Visit 1,Day 1 (For minors: Can be performed at a Visit 2, week 2, +/- 1 week) |
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| 0 |
| 20 |
| 0 |
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| 0 |
| 20 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019538 | Health Care Surveys |
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D006302 | Health Services Research |
| D006285 | Health Planning |
| D004472 | Health Care Economics and Organizations |
| D063868 | Patient Outcome Assessment |
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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