Status:
COMPLETED
Quality Control of CE-Certified Phonak Hearing Aids - Sonova2018_05
Lead Sponsor:
Sonova AG
Conditions:
Hearing Loss, Sensorineural
Eligibility:
All Genders
18-99 years
Phase:
NA
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 ma...
Detailed Description
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 connect...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2018
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03751891
Start Date
March 12 2018
End Date
May 31 2018
Last Update
November 23 2018
Active Locations (1)
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1
Sonova AG
Stäfa, Canton of Zurich, Switzerland, 8712