Quality Control of CE-Certified Phonak Hearing Aids - 2017_13

Sonova

Status: Completed

Conditions: Hearing Loss, Bilateral Sensorineural, Progressive

Treatments: Device: Line extension of the Phonak Audéo B product family; Device: Phonak Audéo B

Study type: Interventional

Funder types: Industry

Identifiers

NCT03131557

Sonova2017_13

Details and patient eligibility

About

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 usability, 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: 20 patients

Sex: All

Ages: 18 to 99 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Line extension of the Phonak Audéo B hearing aid

Experimental group

Description:

The line extension of the Phonak Audéo B product family will be fitted to the participants individual hearing loss.

Treatment:

Device: Line extension of the Phonak Audéo B product family

Phonak Audéo B hearing aid

Active Comparator group

Description:

Phonak Audéo B will be fitted to the participants individual hearing loss.

Treatment:

Device: Phonak Audéo B