Quality Control of CE-Certified Phonak Hearing Aids - Sonova2018_05

Sonova

Status: Completed

Conditions: Hearing Loss, Sensorineural

Treatments: Device: HearingAid_B; Device: Phonak Audéo B90-Direct; Device: HearingAid_A

Study type: Interventional

Funder types: Industry

Identifiers

NCT03751891

Sonova2018_05

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 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 a comparison with a CE-labeled Phonak Receiver-in-the-canal (RIC) device (active comparator) and two CE-labeled competitor devices (RIC) is done. All study devices contain direct connectivity functionality which will be compared in terms of streamed Audio quality, streaming stability and Usability preferences of all available functions and features. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Enrollment: 15 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult hearing impaired persons (minimum age: 18 years, mild to moderate Hearing loss) without hearing aid experience
• 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 an iPhone 6 or higher

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: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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15 participants in 3 patient groups

Phonak Audéo B90-Direct

Experimental group

Description:

The Phonak Audéo B90-Direct is the most recent Receiver-in-the-canal Hearing aid with direct connectivity functionality from Phonak which will be fitted to the participants individual Hearing loss.

Treatment:

Device: Phonak Audéo B90-Direct

HearingAid_A

Active Comparator group

Description:

HearingAid_A is the most recent Receiver-in-the-canal Hearing aid with direct connectivity functionality from manufacturer_A which will be fitted to the participants individual Hearing loss.

Treatment:

Device: HearingAid_A

HearingAid_B

Active Comparator group

Description:

HearingAid_B is the most recent Receiver-in-the-canal Hearing aid with direct connectivity functionality from manufacturer_B which will be fitted to the participants individual Hearing loss.

Treatment:

Device: HearingAid_B