Quality Control of CE-Certified Phonak Hearing Aids – 2019_19

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Brief Title

Quality Control of CE-Certified Phonak Hearing Aids - 2019_19

Official Title

Quality Control of CE-Certified Phonak Hearing Aids - 2019_19

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 Behind-the-ear (BTE) devices is investigated including
      CE-labeled compatible accessories. The experimental device will be investigated regarding its
      performance of speech understanding in noise with and without an accessory existing of an
      external microphone to pick sound at a certain target. 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. Another objective of this study is the
      investigation of the subjective occlusion effect of different acoustic couplings. 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

Speech intelligibility in noise

Secondary Outcome

 Subjective Sound quality perception

Condition

Hearing Loss

Intervention

Phonak Bolero M90-M

Study Arms / Comparison Groups

 Phonak Bolero M90-M
Description:  The Phonak Bolero M90-M is a Behind-the-Ear Hearing aid with direct connectivity functionality 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 Information


Recruitment Status

Device

Estimated Enrollment

20

Start Date

June 3, 2019

Completion Date

July 6, 2019

Primary Completion Date

July 6, 2019

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

          -  Informed Consent as documented by signature

          -  owning a compatible smartphone

          -  Hearing loss in range of N2-N3 (ISO 60118-15)

        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

Administrative Informations


NCT ID

NCT03992989

Organization ID

Sonova2019_19


Responsible Party

Sponsor

Study Sponsor

Sonova AG


Study Sponsor

, , 


Verification Date

July 2020