Clinical trial NCT04774185: Hearing Aid Transmitter Performance Study - SRF-366
Official title: Hearing Aid Transmitter Performance Study - SRF-366
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: Acoustical Coupling
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2021-03-01
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Sonova 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 Sonova Hearing Systems undergo a final quality control in terms of clinical trials. This is a confirmatory study, investigating benefits of a modified hearing aid loudspeaker. This will be a clinical investigation which will be conducted mono centric at National Acoustic Laboratories a well known institution with exceptional experience (Australia).

Detailed description: In this study a comparison with two Phonak Receiver in Canal (RIC) devices is done. The experimental device with a modified hearing aid loudspeaker concept and the active comparator with the existing technology will be compared regarding speech intelligibility, listening effort and sound quality in speech in noise, quiet situations for people with mild to moderate hearing losses.

Eligibility criteria: Inclusion Criteria:

* Adult hearing impaired persons (minimum age: 18 years, mild to moderate Hearing loss)
* Good written and spoken English language skills
* Healthy outer ear
* Ability to fill in a questionnaire (p/eCRF) conscientiously
* Willingness to wear Receiver in Canal hearing aids
* Informed Consent as documented by signature
* Normal cognitive abilities

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 Sydney (AUS)
* 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

Primary outcomes:
measure: Evaluation of speech intelligibility and sound quality for different loudspeaker
timeFrame: 2 weeks
Secondary outcomes:
measure: Evaluation of listening effort for different loudspeaker.
timeFrame: 2 weeks
measure: Evaluation of sound quality of own voice for different loudspeaker.
timeFrame: 2 weeks
measure: Evaluation of sound quality of streamed signals for different loudspeaker
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: National Acoustic Laboratories
Study officials:
affiliation: National Acoustic Laboratories
name: Jorge Meijra, PhD
role: PRINCIPAL_INVESTIGATOR
References: