Brief Title
Quality Control of CE-Certified Phonak Hearing Aids - 2018_42
Official Title
Quality Control of CE-Certified Phonak Hearing Aids - 2018_42
Brief Summary
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
In this study one CE-labeled Phonak Receiver-in-the-canal (RIC) devices is investigated. The experimental device will be investigated regarding Sound Quality perception ot the T-Coil program. 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 and a T-Coil. The combination of a wireless chip for Bluetooth streaming and a T-Coil in one housing can cause audible artifacts on the T-Coil, which shall be investigated within this study. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).
Study Type
Interventional
Primary Outcome
Subjective perception of the T-Coil Sound Quality
Secondary Outcome
Program switch-back workflow into T-Coil program
Condition
Hearing Loss
Intervention
Audéo M90-T
Study Arms / Comparison Groups
Phonak Audéo M90-T
Description: The Phonak Audéo M90-T is a Receiver-in-the-canal Hearing aid with direct connectivity functionality and a T-Coil from Phonak which will be fitted to the participants individual Hearing loss.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
20
Start Date
January 9, 2019
Completion Date
February 28, 2019
Primary Completion Date
February 7, 2019
Eligibility Criteria
Inclusion Criteria: - Adult hearing impaired persons (minimum age: 18 years, moderate to severe Hearing loss) - 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 a compatible smartphone 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
Gender
All
Ages
18 Years - 99 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Switzerland
Location Countries
Switzerland
Administrative Informations
NCT ID
NCT03938753
Organization ID
Sonova2018_42
Responsible Party
Sponsor
Study Sponsor
Sonova AG
Study Sponsor
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Verification Date
May 2019