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

NCT ID: NCT04723173

Last Updated: 2022-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-07
• Study Completion Date: 2021-06-07

Brief Summary

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).

Detailed 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).

Conditions

Hearing Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Experimental device: Noise reduction on

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.

Group Type: EXPERIMENTAL

Feature for noise reduction (on)

Intervention Type: DEVICE

The noise reduction feature shall support the hearing aid user in noisy situations and shall reduce the listening effort.

Experimental device: Noise reduction off

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

Group Type: ACTIVE_COMPARATOR

Feature for noise reduction (off)

Intervention Type: DEVICE

To show the advantage of the noise reduction feature there is a comparison without the feature necessary.

Interventions

Feature for noise reduction (on)

The noise reduction feature shall support the hearing aid user in noisy situations and shall reduce the listening effort.

Intervention Type: DEVICE

Feature for noise reduction (off)

To show the advantage of the noise reduction feature there is a comparison without the feature necessary.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sonova AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sonova AG

Stäfa, Canton of Zurich, Switzerland

Countries

Switzerland

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Sonova2020_43

Identifier Type: -

Identifier Source: org_study_id