Quality Control of CE-Certified Phonak Hearing Aids - 2017_37

NCT ID: NCT03379766

Last Updated: 2018-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-08
• Study Completion Date: 2018-02-02

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 and functions. 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

Successor of Phonak Audéo B-Direct

The successor of Phonak Audéo B-Direct will be fitted to the participants individual hearing loss.

Group Type: EXPERIMENTAL

Successor of Phonak Audéo B-Direct

Intervention Type: DEVICE

The successor of Phonak Audéo B-Direct will be fitted to the participants indivudal hearing loss.

Phonak Audéo B-Direct

The Phonak Audéo B-Direct will be fitted to the participants individual hearing loss.

Group Type: ACTIVE_COMPARATOR

Phonak Audéo B-Direct

Intervention Type: DEVICE

The Phonak Audéo B-Direct will be fitted to the participants individual hearing loss.

Interventions

Successor of Phonak Audéo B-Direct

The successor of Phonak Audéo B-Direct will be fitted to the participants indivudal hearing loss.

Intervention Type: DEVICE

Phonak Audéo B-Direct

The Phonak Audéo B-Direct will be fitted to the participants individual hearing loss.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adult hearing impaired persons (minimum age: 18 years) with at least 3 months experience with hearing aids
• Good written and spoken (Swiss) German language skills
• Healthy outer ear
• Ability to fill in a questionnaire (p/eCRF) conscientiously
• 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
• Massively limited dexterity
• Known psychological problems
• Central hearing disorders

• 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, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

Sonova2017_37

Identifier Type: -

Identifier Source: org_study_id