Hearing Aid Transmitter Performance Study - SRF-366

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).

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: New hearing aid loudspeaker; Device: Standard hearing aid loudspeaker

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Sydney, Australia
    • National Acoustic Laboratories

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: New hearing aid loudspeaker; 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.	Device: New hearing aid loudspeaker; The new hearing aid loudspeaker will be fitted to the participants individual ear anatomy and hearing loss.
Active Comparator: Standard hearing aid loudspeaker; 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.	Device: Standard hearing aid loudspeaker; The standard hearing aid loudspeaker will be fitted to the participants individual ear anatomy and hearing loss.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of speech intelligibility and sound quality for different loudspeaker	The Primary Outcome measure of this study is the comparison of the standard hearing aid loudspeaker with the modified one in regard to speech intelligibility in a noisy environment and sound quality in a quiet situation. The speech intelligibility will be measured using a speech test in dB SRT and the sound quality will be assessed by subjective rating, using percentage of satisfaction from "very satisfied (100)" to "very unsatisfied (0)".	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of listening effort for different loudspeaker.	The Secondary Outcome measure of this study is the comparison of the standard hearing aid loudspeaker with the modified one in regard to listening effort in a noisy environment. The listening effort of speech will be assessed by subjective rating, within 13 steps, from "not effortful at all" to "only noise".	2 weeks
Evaluation of sound quality of own voice for different loudspeaker.	The Secondary Outcome measure of this study is the comparison of the standard hearing aid loudspeaker with the modified one in regard to sound quality in quiet. The sound quality of own voice will be assessed by subjective rating, using percentage of satisfaction from "very satisfied (100)" to "very unsatisfied (0)".	2 weeks
Evaluation of sound quality of streamed signals for different loudspeaker	The Secondary Outcome measure of this study is the comparison of the standard hearing aid loudspeaker with the modified one in regard to sound quality of a streamed signal in quiet and noise.. The sound quality of the streamed signal will be assessed by subjective rating, using percentage of satisfaction from "very satisfied (100)" to "very unsatisfied (0)".	2 weeks

Collaborators and Investigators

• Sponsor: Sonova AG

Publications and helpful links

Helpful Links

• ActiveVent™ Receiver provides benefit of open and --closed acoustics for better speech understanding in noise and naturalness of own voice perception

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2021
• Primary Completion (Actual): April 25, 2022
• Study Completion (Actual): April 25, 2022

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 24, 2023
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Acoustical Coupling
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: SRF-366

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No