Quality Control of CE-Certified Phonak Hearing Aids – 2018_42

Brief Title

Quality Control of CE-Certified Phonak Hearing Aids - 2018_42

Official Title

Quality Control of CE-Certified Phonak Hearing Aids - 2018_42

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

Detailed Description

      In this study one CE-labeled Phonak Receiver-in-the-canal (RIC) devices is investigated. The
      experimental device will be investigated regarding Sound Quality perception ot the T-Coil
      program. A secondary objective of this study is the investigation of the Overall system
      stability in daily life situations. The experimental device contains direct connectivity
      functionality and a T-Coil. The combination of a wireless chip for Bluetooth streaming and a
      T-Coil in one housing can cause audible artifacts on the T-Coil, which shall be investigated
      within this study. This will be a clinical evaluation which will be conducted mono centric at
      Sonova AG Headquarters based in Stäfa (Switzerland).
    

Study Type

Interventional

Primary Outcome

Subjective perception of the T-Coil Sound Quality

Secondary Outcome

 Program switch-back workflow into T-Coil program

Condition

Hearing Loss

Intervention

Audéo M90-T

Study Arms / Comparison Groups

 Phonak Audéo M90-T

Description:  The Phonak Audéo M90-T is a Receiver-in-the-canal Hearing aid with direct connectivity functionality and a T-Coil from Phonak which will be fitted to the participants individual Hearing loss.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Device

Estimated Enrollment

20

Start Date

January 9, 2019

Completion Date

February 28, 2019

Primary Completion Date

February 7, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Adult hearing impaired persons (minimum age: 18 years, moderate to severe 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 Receiver in the canal hearing aids

          -  Informed Consent as documented by signature

          -  Owning a compatible smartphone

        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
      

Gender

All

Ages

18 Years - 99 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Switzerland

Location Countries

Switzerland

NCT ID

NCT03938753

Organization ID

Sonova2018_42

Responsible Party

Sponsor

Study Sponsor

Sonova AG

Study Sponsor

, , 

Verification Date

May 2019