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Completed

NCT Number: NCT04774185

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).

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Acoustic Laboratories

Sydney, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

New hearing aid loudspeaker

Device

The new hearing aid loudspeaker will be fitted to the participants individual ear anatomy and hearing loss.

Standard hearing aid loudspeaker

Device

The standard hearing aid loudspeaker will be fitted to the participants individual ear anatomy and hearing loss.

Primary outcomes

  1. Evaluation of speech intelligibility and sound quality for different loudspeaker

    Time frame: 2 weeks

    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)".

Secondary outcomes

  1. Evaluation of listening effort for different loudspeaker.

    Time frame: 2 weeks

    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. Evaluation of sound quality of own voice for different loudspeaker.

    Time frame: 2 weeks

    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)".

  3. Evaluation of sound quality of streamed signals for different loudspeaker

    Time frame: 2 weeks

    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)".

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 1, 2021
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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