Status:
COMPLETED
Quality Control of CE-Certified Phonak Hearing Aids - 2017_27
Lead Sponsor:
Sonova AG
Conditions:
Hearing Loss, Bilateral Sensorineural, Progressive
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of participants with a hearing loss to grant quality control prior to product launch. The aim of t...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Adult hearing impaired persons (minimum age: 18 years) with and without (experience with) hearing aids
- 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
- Smartphone user
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
- Massively limited dexterity
- Known psychological problems
- Central hearing disorders
Key Trial Info
Start Date :
August 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 25 2017
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03253003
Start Date
August 7 2017
End Date
August 25 2017
Last Update
September 25 2017
Active Locations (1)
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1
Sonova AG
Stäfa, Canton of Zurich, Switzerland, 8712