Quality Control of CE-Certified Phonak Hearing Aids - Sonova2018_05

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 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 a comparison with a CE-labeled Phonak Receiver-in-the-canal (RIC) device (active comparator) and two CE-labeled competitor devices (RIC) is done. All study devices contain direct connectivity functionality which will be compared in terms of streamed Audio quality, streaming stability and Usability preferences of all available functions and features. 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 - Sonova2018_05

Conditions
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Hearing Loss, Sensorineural

Intervention / Treatment
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* Device: Phonak Audéo B90-Direct
* Device: HearingAid_A
* Device: HearingAid_B


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 willingness to wear Receiver in the canal hearing aids Informed Consent as documented by signature owning an iPhone 6 or higher 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phonak Audéo B90-Direct<br>The Phonak Audéo B90-Direct is the most recent Receiver-in-the-canal Hearing aid with direct connectivity functionality from Phonak which will be fitted to the participants individual Hearing loss. | Device: Phonak Audéo B90-Direct<br>* The Phonak Audéo B90-Direct is the most recent Receiver-in-the-canal Hearing aid from Phonak which will be fitted to the participants individual Hearing loss.<br>|
| Active Comparator: HearingAid_A<br>HearingAid_A is the most recent Receiver-in-the-canal Hearing aid with direct connectivity functionality from manufacturer_A which will be fitted to the participants individual Hearing loss. | Device: HearingAid_A<br>* HearingAid_A is the most recent Receiver-in-the-canal Hearing aid from manufacturer_A which will be fitted to the participants individual Hearing loss.<br>|
| Active Comparator: HearingAid_B<br>HearingAid_B is the most recent Receiver-in-the-canal Hearing aid with direct connectivity functionality from manufacturer_B which will be fitted to the participants individual Hearing loss. | Device: HearingAid_B<br>* HearingAid_B is the most recent Receiver-in-the-canal Hearing aid from manufacturer_B which will be fitted to the participants individual Hearing loss.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the speech intelligibiltity of phone calls via direct streaming | The primary outcome meaurement of this study is the comparison of Phonak's direct connectivity solution against two competitors in terms of subjective speech intelligibility of streamed audio signals via smartphone. The subjective speech intelligibilty will be measured via interview (sound quality rating, satisfaction rating of speech intelligibility) from far-end talker and near-end talker. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigation of Bluetooth Connection losses between Hearing Aid and smart phone during a phone call (number of reported interruptions during a phone call which will be streamed via bluetooth from Smartphone to Hearing Aid) | The secondary outcome measurement of this study is to investigate the number of (Bluetooth-) Connection losses between Hearing Aid and Smartphone during a phone call stream. The bluetooth connection losses will be investigated by counting the reported interruptions of a streamed phone call between smartphone and Hearing Aid in relation to the amount of conducted phone calls during two weeks of home trial for the investigational device and the comparative devices. | 6 weeks |