Quality Control of CE-Certified Phonak Hearing Aids - 2018_42

Sonova

Status: Completed

Conditions: Hearing Loss; Sensorineural Hearing Loss

Treatments: Device: Audéo M90-T

Study type: Interventional

Funder types: Industry

Identifiers

NCT03938753

Sonova2018_42

Details and patient eligibility

About

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. This is a pre-validation study, investigating optimized algorithms, features, functions and wearing comfort. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Full description

In this study one CE-labeled Phonak Receiver-in-the-canal (RIC) devices is investigated. The experimental device will be investigated regarding Sound Quality perception ot the T-Coil program. A secondary objective of this study is the investigation of the Overall system stability in daily life situations. The experimental device contains direct connectivity functionality and a T-Coil. The combination of a wireless chip for Bluetooth streaming and a T-Coil in one housing can cause audible artifacts on the T-Coil, which shall be investigated within this study. This will be a 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, moderate to severe Hearing loss)
• Good written and spoken (Swiss) German language skills
• Healthy outer ear
• Ability to fill in a questionnaire (p/eCRF) conscientiously
• Willingness to wear Receiver in the canal hearing aids
• Informed Consent as documented by signature
• Owning a compatible smartphone

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
• Known psychological problems
• Central hearing disorders

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Phonak Audéo M90-T

Experimental group

Description:

The Phonak Audéo M90-T is a Receiver-in-the-canal Hearing aid with direct connectivity functionality and a T-Coil from Phonak which will be fitted to the participants individual Hearing loss.

Treatment:

Device: Audéo M90-T