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Quality Control of CE-Certified Phonak Hearing Aids - 2020_43

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ClinicalTrials.gov Identifier: NCT04723173
Recruitment Status : Suspended (Corona)
First Posted : January 25, 2021
Last Update Posted : January 29, 2021
Sponsor:
Information provided by (Responsible Party):
Sonova AG

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

Condition or disease Intervention/treatment Phase
Hearing Loss Device: Successor of Phonak Naida B90 Device: Phonak Naida B90 Not Applicable

Detailed Description:
In this study a comparison with two CE-labeled Phonak behind the ear (BTE) devices is done. The experimental device and the active comparator will be compared regarding Sound Quality perception and the ability of detecting soft sounds. This study shall investigate the listening effort in a noisy environment with noise reduction on vs. off in the experimental device, for people with severe to profound hearing losses. This will be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Quality Control of CE-Certified Phonak Hearing Aids - 2020_43
Actual Study Start Date : December 7, 2020
Estimated Primary Completion Date : February 12, 2021
Estimated Study Completion Date : February 12, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Successor of Phonak NaidaB 90
The successor of the Phonak NaidaB 90 is a Behind-the-ear Hearing aid which will be fitted to the participants individual Hearing loss.
Device: Successor of Phonak Naida B90
The successor of the Phonak NaidaB 90 is a Behind-the-ear Hearing aid which will be fitted to the participants individual Hearing loss.

Active Comparator: Phonak NaidaB 90
The Phonak NaidaB 90 is a Behind-the-ear Hearing aid from Phonak for hearing impaired people with severe to profound hearing losses which will be fitted to the participants individual Hearing loss.
Device: Phonak Naida B90
The Phonak NaidaB 90 is a Behind-the-ear Hearing aid from Phonak for hearing impaired people with severe to profound hearing losses which will be fitted to the participants individual Hearing loss.




Primary Outcome Measures :
  1. Evaluation of listening effort for different feature settings [ Time Frame: 1 weeks ]

    The Primary Outcome measure of this study is the comparison of the noise canceler off vs on with the experimental Hearing aid in regard to listening effort in a noisy environment.

    The listening effort will be measured by a subjective rating, with 11 steps, from "very easy to understand" to "not hearable".



Secondary Outcome Measures :
  1. Evaluating the subjective acceptance of sound [ Time Frame: 1 week ]

    The secondary Outcome measure of this study is the Evaluation of the sound quality, when the available gain will be increased by the feedback manager.

    The acceptance will be measured by a subjective rating (very unsatisfied-unsatisfied-neither-satisfied-very satisfied).


  2. Evaluating the ability of detecting sound [ Time Frame: 2 weeks ]

    The secondary Outcome measure of this study is the Evaluation of ability of detecting sounds in a quiet environment, compared between the experimental device and the comparator.

    The ability will be measured by a detection threshold.




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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult hearing impaired persons (minimum age: 18 years, severe to profound 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 Behind-the-ear hearing aids
  • 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
  • Known psychological problems

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04723173


Locations
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Switzerland
Sonova AG
Stäfa, Zürich, Switzerland, 8712
Sponsors and Collaborators
Sonova AG
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Responsible Party: Sonova AG
ClinicalTrials.gov Identifier: NCT04723173    
Other Study ID Numbers: Sonova2020_43
First Posted: January 25, 2021    Key Record Dates
Last Update Posted: January 29, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases