Quality Control of CE-Certified Phonak Hearing Aids - 2019_19

Study Overview
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Brief Summary
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Phonak Hearing Systems pass through different development and study stages. 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, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials. This is a pre-validation study, investigating optimized algorithms, features, functions and wearing comfort. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Detailed Description
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In this study one CE-labeled Phonak Behind-the-ear (BTE) devices is investigated including CE-labeled compatible accessories. The experimental device will be investigated regarding its performance of speech understanding in noise with and without an accessory existing of an external microphone to pick sound at a certain target. A secondary objective of this study is the investigation of the Overall system stability in daily life situations. The experimental device contains direct connectivity functionality. Another objective of this study is the investigation of the subjective occlusion effect of different acoustic couplings. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Official Title
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Quality Control of CE-Certified Phonak Hearing Aids - 2019_19

Conditions
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Hearing Loss, Sensorineural Hearing Loss

Intervention / Treatment
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* Device: Phonak Bolero M90-M
* Device: Roger Select


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult hearing impaired persons (minimum age: 18 years, mild to moderate Hearing loss) without hearing aid experience Good written and spoken (Swiss) German language skills Healthy outer ear Ability to fill in a questionnaire (p/eCRF) conscientiously Informed Consent as documented by signature owning a compatible smartphone Hearing loss in range of N2-N3 (ISO 60118-15) Exclusion Criteria: Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product Limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland) Limited ability to describe listening impressions/experiences and the use of the hearing aid Inability to produce a reliable hearing test result Known psychological problems Central hearing disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phonak Bolero M90-M<br>The Phonak Bolero M90-M is a Behind-the-Ear Hearing aid with direct connectivity functionality from Phonak which will be fitted to the participants individual Hearing loss | Device: Phonak Bolero M90-M<br>* The Phonak Bolero M90-M is a Behind-the-Ear Hearing aid with direct connectivity functionality from Phonak which will be fitted to the participants individual Hearing loss<br>|
| Active Comparator: Roger Select<br>The Roger Select is an accessory which can be connected to a compatible hearing aid. It offers an external microphone which streams signals directly to the connected hearing aid. | Device: Roger Select<br>* The Roger Select is an accessory which can be connected to a compatible hearing aid. It offers an external microphone which streams signals directly to the connected hearing aid.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech intelligibility in noise | The primary objective of this study is to investigate the speech intelligibility in noise of the investigational device alone versus the active comparator. Speech understanding in noise will be evaluated with an objective and validated test procedure, the Outcome measure will be the value of speech intelligibility in percentage at a certain signal to noise ratio. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Sound quality perception | The secondary objective of this study is to investigate the overall sound quality perception of the investigational device for daily real life situations. The sound quality perception will be measured with a subjective satisfaction rating scale ranging from 0% to 100%. | 4 weeks |