Quality Control of CE-Labelled Phonak Hearing Systems (Study Part: Sonova2015-00)

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Sonova

Status

Completed

Conditions

Hearing Loss

Treatments

Device: Equivalent competitor device
Device: Phonak's equivalent newly developped power BTE

Study type

Interventional

Funder types

Industry

Identifiers

NCT02754843
Sonova2015-00

Details and patient eligibility

About

The purpose of this study, which contains a series of successive study parts, is to methodically evaluate Phonak Hearing Systems on hard of hearing participants to grant quality control prior to each product launch.

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Hearing impaired persons with and without (experience with) hearing aids
  • Good written and spoken (Swiss) German language skills
  • Healthy outer ear (without previous surgical procedures)
  • Ability to fill in a questionnaire conscientiously
  • Informed Consent as documented by signature

Exclusion criteria

  • Contraindications to the medical device in this study, e.g. known hypersensitivity or allergy to the investigational product
  • Limited mobility and not in the position to attend weekly appointments
  • 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

Trial design

27 participants in 2 patient groups

Naida Q90-SP
Active Comparator group
Description:
Phonak's commercial power Behind-The-Ear (BTE) device, type 1.
Treatment:
Device: Phonak's equivalent newly developped power BTE
Device: Equivalent competitor device
Naida Q90-UP
Active Comparator group
Description:
Phonak's commercial power Behind-The-Ear (BTE) device, type 2.
Treatment:
Device: Phonak's equivalent newly developped power BTE
Device: Equivalent competitor device

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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