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

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.
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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.
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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. |
- 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".
- 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).
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Switzerland | |
Sonova AG | |
Stäfa, Zürich, Switzerland, 8712 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hearing Loss Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases |
Sensation Disorders Neurologic Manifestations Nervous System Diseases |