Quality Control of CE-Certified Phonak Hearing Aids - 2020_26
Status
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Details and patient eligibility
About
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).
Full description
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
24 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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