Quality Control of CE-Certified Phonak Hearing Aids - 2020_26

Study Overview
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Brief Summary
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Phonak Hearing Devices pass through different development and study phases. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, resulting from the pre-validation studies, they get optimized. Prior to product launch, the Phonak Hearing Systems get reviewed by a final quality control in terms of clinical trials. This is a validation study, investigating improved algorithms, features, functions and wearing comfort. This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Detailed Description
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This study will investigate the combination of the features to determine if the audiological performance and quality of the new successor of the Marvel family shows an improved benefit over Phonak Audéo Marvel before going into the System Validation. Therefore this study will be a comparative study. The study will determine if hearing impaired users wearing the successor hearing aids, have better initial acceptance with the new precalculation, better sound quality and speech intelligibility, more clarity and loudness comfort in soft and loud environments compared to Phonak Marvel RIC (Receiver in channel) hearing aids. Another objective of the study is to compare the listening effort with the two different study devices.

Official Title
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Quality Control of CE-Certified Phonak Hearing Aids - 2020_26

Conditions
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Hearing Loss

Intervention / Treatment
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* Device: RIC (Receiver in Canal) hearing aid/ hearing instrument (HI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hearing Loss range: N3-N4 experienced hearing aid user willingness to wear behind the ear hearing aids Informed Consent as documented by signature Exclusion Criteria: the audiogram is not in the fitting range of the intended hearing aid first time user limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland) participant is not able to describe experiences and hearing impressions allergies against the material of the hearing aid

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Successor of Phonak Audéo M-90<br>Phonak Hearing instrument (HI) with modified precalculation. | Device: RIC (Receiver in Canal) hearing aid/ hearing instrument (HI)<br>* HI is developed to support hearing impaired people in calm and complex situations and to be able to participate in communication<br>|
| Active Comparator: Phonak Audéo M-90<br>Phonak Audéo M-90 is the most recent RIC device from Phonak which will be fitted to the participants individual hearing loss. | Device: RIC (Receiver in Canal) hearing aid/ hearing instrument (HI)<br>* HI is developed to support hearing impaired people in calm and complex situations and to be able to participate in communication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rating of the sound quality for the new and the comparative HI | Subjective rating of the overall satisfaction for sound quality by questionnaires for the new HI and the old comparative HI (%). The participants rates after one week home trial. The home trial is randomized. The questionnaire includes rating scales for the satisfaction. The participant has to rate it in percentage (100% = very satisfy, 0% = very unsatisfy) | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech intelligibility in noisy situations (only test device) | Evaluating the speech intelligibility with the test device, using a speech in noise test, Oldenburger Satztest (OLSA) after the subject set the noise cancellation via an App on an individual limit. The results of the test are the word recognition score in SNR. | 4 week | 
| Speech intelligibility in quiet situations | Evaluating and comparing the speech intelligibility in a quiet test situation of the test device and the Marvel device. Using the Reimtest nach Wallenberg und Kollmeier (WaKo ) (%). | 4 week | 
| Speech intelligibility in noisy situations | Evaluating and comparing the speech intelligibility in a noisy test situation of the test device and competitor. Using the OLSA (word recognition score) | 4 weeks | 
| Rating of sound quality | Subjective rating of the overall satisfaction for sound quality by questionnaires for the new HI and the old comparative HI (%). The participants rates after the First Fit. The questionnaire includes rating scales for the satisfaction. The participant has to rate it in percentage (100% = very satisfy, 0% = very unsatisfy) | 1 week |