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

Sonova

Status: Completed

Conditions: Hearing Loss

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

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: Equivalent competitor device

Device: Phonak's equivalent newly developped power BTE

Naida Q90-UP

Active Comparator group

Description:

Phonak's commercial power Behind-The-Ear (BTE) device, type 2.

Treatment:

Device: Equivalent competitor device

Device: Phonak's equivalent newly developped power BTE