Quality Control of CE-Certified Phonak Hearing Aids - 2016_05

Sonova

Status

Completed

Conditions

Hearing Loss

Treatments

Device: Hearing Aid

Study type

Interventional

Funder types

Industry

Identifiers

NCT02951247

Sonova2016_05

Details and patient eligibility

About

A methodical evaluation of new CE-labelled Phonak Hearing Systems is intended to be conducted on hard of hearing participants 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.

Full 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 manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials in the way as planned for this study ("phase of final inspection"). This will be a controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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