CompletedNot Applicable

Quality Control of CE-Certified Phonak Hearing Aids - 2016_37

Switzerland20 participantsStarted 2017-04-03

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 zero-defect overall performance of the new hearing systems as well as maximum benefit for the participant with the devices in comparison to previously outstanding Phonak Hearing Systems.

Who can participate

Age range18 Years – 99 Years

SexALL

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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 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

Speech intelligibility in noise as signal to noise ratio in dB (dB SNR)

Timeframe: Three weeks

Trial details

NCT IDNCT03108768

SponsorSonova AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-06-14

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