Quality Control of CE-Certified Phonak Hearing Aids - 2020_43

Sonova

Status: Completed

Conditions: Hearing Loss

Treatments: Device: Feature for noise reduction (on); Device: Feature for noise reduction (off)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04723173

Sonova2020_43

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 investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Full description

The study will compare different features of the Phonak behind the ear device activated and deactivated, for example the noise reduction feature. There shall be differences in listening effort, awareness and sound quality shown. The study shall show the advantages especially for people with severe to profound hearing losses. This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Enrollment: 10 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult hearing impaired persons (minimum age: 18 years, severe to profound 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 Behind-the-ear hearing aids
• 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
• Known psychological problems

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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10 participants in 2 patient groups

Experimental device: Noise reduction on

Experimental group

Description:

The noise reduction is activated. The feature shall support the hearing aid user in noisy situation and shall reduce the listening effort in these special situations.

Treatment:

Device: Feature for noise reduction (on)

Experimental device: Noise reduction off

Active Comparator group

Description:

To compare the advantage of the special noise reduction feature the tests will be done additionally with the deactivated feature.

Treatment:

Device: Feature for noise reduction (off)