Investigating Hearing With the Ponto 4, a Bone Anchored Hearing Aid

Study Overview
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Brief Summary
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The study is a prospective, 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.

Detailed Description
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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 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. 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.

Official Title
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Investigating Hearing With the Ponto 4, a Bone Anchored Hearing Aid

Conditions
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Hearing Loss, Conductive, Hearing Loss, Mixed

Intervention / Treatment
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* Device: Audiometry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed Informed Consent Form 12 years old and above Subjects with hearing loss fitted unilaterally or bilaterally with the Ponto 4(s) on abutment at least 1.5 months prior to being enrolled in the study Fluent in local language, as judged by the investigator Exclusion Criteria: Participation in another clinical investigation which might cause interference with study participation. Subjects who do not have the ability or are un-willing to follow investigational procedures/requirements, e.g. to complete patient related outcome (PRO's) according to investigators discretion

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single arm<br>Asessments for the hearing with Ponto 4 sound processor on the implanted ear(s). | Device: Audiometry<br>* 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.<br>* Other names: Patient reported outcomes;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | Visit 1, Day 1 | 

Secondary Outcome Measures

| Outcome Measure | 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. | Visit 1, Day 1 | 
| 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. | 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). | 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. Effective gain with Ponto 4, see definition above, calculated in average for frequencies 500, 1000, 2000 and 4000 Hz (PTA4). | After study completion, 6 months | 
| H. To evaluate the above objectives on individual levels | 1. Endpoints A1, B1, C1 analyzed as the proportion of subjects whose performance is better or equal in the unaided to aided comparisons, i.e. have a difference ≥0 | After study completion, 6 months | 
| 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 | After study completion, 6 months | 
| 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. | After study completion, 6 months | 
| 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 frequencis 500, 1000, 2000 and 4000 Hz from audiogram measured at the study visit and the fitting visit. | After study completion, 6 moths | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hearing loss, hearing disorder,, ear diseases, BAHS