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

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

Study Description

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).

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

Switzerland

Sonova AG

Stäfa, Zürich, Switzerland, 8712

Sponsors and Collaborators

Sonova AG

More Information

• Responsible Party: Sonova AG
• ClinicalTrials.gov Identifier: NCT04723173
• Other Study ID Numbers: Sonova2020_43
• First Posted: January 25, 2021
• 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

Additional relevant MeSH terms:

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases