Quality Control of CE-Certified Phonak Hearing Aids - 2020_26

NCT ID: NCT04496791

Last Updated: 2020-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2020-08-07

Brief Summary

Phonak Hearing Devices pass through different development and study phases. 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, resulting from the pre-validation studies, they get optimized. Prior to product launch, the Phonak Hearing Systems get reviewed by a final quality control in terms of clinical trials. This is a validation study, investigating improved 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

This study will investigate the combination of the features to determine if the audiological performance and quality of the new successor of the Marvel family shows an improved benefit over Phonak Audéo Marvel before going into the System Validation. Therefore this study will be a comparative study. The study will determine if hearing impaired users wearing the successor hearing aids, have better initial acceptance with the new precalculation, better sound quality and speech intelligibility, more clarity and loudness comfort in soft and loud environments compared to Phonak Marvel RIC (Receiver in channel) hearing aids. Another objective of the study is to compare the listening effort with the two different study devices.

Conditions

Hearing Loss

Study Design

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

Study Groups

Successor of Phonak Audéo M-90

Phonak Hearing instrument (HI) with modified precalculation.

Group Type: EXPERIMENTAL

RIC (Receiver in Canal) hearing aid/ hearing instrument (HI)

Intervention Type: DEVICE

HI is developed to support hearing impaired people in calm and complex situations and to be able to participate in communication

Phonak Audéo M-90

Phonak Audéo M-90 is the most recent RIC device from Phonak which will be fitted to the participants individual hearing loss.

Group Type: ACTIVE_COMPARATOR

RIC (Receiver in Canal) hearing aid/ hearing instrument (HI)

Intervention Type: DEVICE

HI is developed to support hearing impaired people in calm and complex situations and to be able to participate in communication

Interventions

RIC (Receiver in Canal) hearing aid/ hearing instrument (HI)

HI is developed to support hearing impaired people in calm and complex situations and to be able to participate in communication

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Hearing Loss range: N3-N4
• experienced hearing aid user
• willingness to wear behind the ear hearing aids
• Informed Consent as documented by signature

Exclusion Criteria

• the audiogram is not in the fitting range of the intended hearing aid
• first time user
• limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
• participant is not able to describe experiences and hearing impressions
• allergies against the material of the hearing aid

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

Sponsors

Sonova AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sonova AG

Stäfa, , Switzerland

Countries

Switzerland

Other Identifiers

Sonova2020_26

Identifier Type: -

Identifier Source: org_study_id