Hearing Aid Transmitter Performance Study - SRF-366

Sonova

Status: Completed

Conditions: Hearing Loss

Treatments: Device: New hearing aid loudspeaker; Device: Standard hearing aid loudspeaker

Study type: Interventional

Funder types: Industry

Identifiers

NCT04774185

SRF-366

Details and patient eligibility

About

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).

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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23 participants in 2 patient groups

New hearing aid loudspeaker

Experimental group

Description:

The new hearing aid loudspeaker is a loudspeaker system with a modified acoustic coupling approach which will be fitted based on the participants' individual ear anatomy.

Treatment:

Device: New hearing aid loudspeaker

Standard hearing aid loudspeaker

Active Comparator group

Description:

The hearing aid loudspeaker is a loudspeaker system with the existing acoustic coupling approach which will be fitted based on the participants' individual ear anatomy.

Treatment:

Device: Standard hearing aid loudspeaker