Quality Control of CE-Certified Phonak Hearing Aids - Sonova2018_05

NCT ID: NCT03751891

Last Updated: 2018-11-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-12
• Study Completion Date: 2018-05-31

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 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).

Detailed 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).

Conditions

Hearing Loss, Sensorineural

Study Design

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

Study Groups

Phonak Audéo B90-Direct

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.

Group Type: EXPERIMENTAL

Phonak Audéo B90-Direct

Intervention Type: DEVICE

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

HearingAid_A

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.

Group Type: ACTIVE_COMPARATOR

HearingAid_A

Intervention Type: DEVICE

HearingAid\_A is the most recent Receiver-in-the-canal Hearing aid from manufacturer\_A which will be fitted to the participants individual Hearing loss.

HearingAid_B

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.

Group Type: ACTIVE_COMPARATOR

HearingAid_B

Intervention Type: DEVICE

HearingAid\_B is the most recent Receiver-in-the-canal Hearing aid from manufacturer\_B which will be fitted to the participants individual Hearing loss.

Interventions

Phonak Audéo B90-Direct

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

Intervention Type: DEVICE

HearingAid_A

HearingAid\_A is the most recent Receiver-in-the-canal Hearing aid from manufacturer\_A which will be fitted to the participants individual Hearing loss.

Intervention Type: DEVICE

HearingAid_B

HearingAid\_B is the most recent Receiver-in-the-canal Hearing aid from manufacturer\_B which will be fitted to the participants individual Hearing loss.

Intervention Type: DEVICE

Eligibility Criteria

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

• 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

Other Identifiers

Sonova2018_05

Identifier Type: -

Identifier Source: org_study_id