Hearing Aid Transmitter Performance Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-26

Study Completion Date

2022-04-25

Brief Summary

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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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Detailed Description

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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.

Conditions

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Hearing Loss

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

New hearing aid loudspeaker

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

Standard hearing aid loudspeaker

Intervention Type DEVICE

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

Interventions

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New hearing aid loudspeaker

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

Intervention Type DEVICE

Standard hearing aid loudspeaker

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No