Brief Title
Quality Control of CE-Certified Phonak Hearing Aids - 2019_19
Official Title
Quality Control of CE-Certified Phonak Hearing Aids - 2019_19
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 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).
Study Type
Interventional
Primary Outcome
Speech intelligibility in noise
Secondary Outcome
Subjective Sound quality perception
Condition
Hearing Loss
Intervention
Phonak Bolero M90-M
Study Arms / Comparison Groups
Phonak Bolero M90-M
Description: 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
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
June 3, 2019
Completion Date
July 6, 2019
Primary Completion Date
July 6, 2019
Eligibility Criteria
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
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
NCT03992989
Organization ID
Sonova2019_19
Responsible Party
Sponsor
Study Sponsor
Sonova AG
Study Sponsor
, ,
Verification Date
July 2020