CompletedNot Applicable

Quality Control of CE-Certified Phonak Hearing Aids - 2017_27

Switzerland19 participantsStarted 2017-08-07

Plain-language 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 the investigation series is to ensure a stable overall performance of the new hearing systems, a good sound quality during phone calls as well as maximum benefit for the participant with the devices.

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 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 * Massively limited dexterity * Known psychological problems * Central hearing disorders

What they're measuring

Stable performance in daily life

Timeframe: Three weeks

Phone call - Sound Quality

Timeframe: One week

Trial details

NCT IDNCT03253003

SponsorSonova AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-08-25

View on ClinicalTrials.gov More Hearing Loss, Bilateral Sensorineural, Progressive trials