A Clinical Investigation of the Benefit: BTE Hearing Aids Versus ITE Hearing Aids

NCT ID: NCT04168229

Last Updated: 2019-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-12
• Study Completion Date: 2018-08-13

Brief Summary

The current study will evaluate a new in-the-ear (ITE) hearing aid hardware. The goal is to evaluate the audiological performance, usability, feature function, and to identify unexpected or unwanted behaviour from the devices. The study plans to compare the behind-the-ear (BTE) hardware style with the ITE devices regarding the benefit received from different microphone locations.

Detailed Description

Hearing aids constantly undergo incremental improvements from already marketed devices. The new devices are expected to perform as well or better than the previous ITE devices.

The aim of the testing is to grant quality control prior to product launch according to Bernafon development requirements.

The current study will evaluate a new ITE hearing aid hardware. The firmware driving the hearing aid has already been sold on the market using the BTE hardware for almost one year and will now be launched using the ITE custom hardware. The goal is to evaluate the audiological performance, usability, feature function, and to identify unexpected or unwanted behaviour from the devices. The study plans to compare the two hardware styles regarding the benefit received from different microphone locations.

As human subjects are involved the validation falls under the definition of a clinical investigation. The validation will address the performance of the new chip using the ITE hardware, and ensure that there is no reduction in speech understanding between using the BTE and ITE hardware styles. Evaluating the overall performance of the Mermaid 9 ITE devices is important to validate that the end user is satisfied with the devices and that all user requirements are fulfilled. All features available in Mermaid 9 have been validated and are currently used on the market in Mermaid 9 BTE devices.

Conditions

Hearing Loss

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ITE Hearing Aid

The subjects will wear the ITE devices in a field test for 10 +/-7 days. At the second and third visits they will perform speech testing in the lab in three randomized conditions (unaided, aided with ITE, and aided with BTE).

Group Type: EXPERIMENTAL

Mermaid 9 ITE

Intervention Type: DEVICE

A Hearing aid intended to amplify sounds and deliver them to the ear with a microphone and receiver housed in an in-the-ear hardware.

BTE Hearing Aid

The subjects will wear the BTE devices in a field test for 10 +/-7 days. At the second and third visits they will perform speech testing in the lab in three randomized conditions (unaided, aided with ITE, and aided with BTE).

Group Type: ACTIVE_COMPARATOR

Mermaid 9 BTE

Intervention Type: DEVICE

A Hearing aid intended to amplify sounds and deliver them to the ear with a microphone and Receiver housed in a behind-the-ear hardware.

Interventions

Mermaid 9 ITE

A Hearing aid intended to amplify sounds and deliver them to the ear with a microphone and receiver housed in an in-the-ear hardware.

Intervention Type: DEVICE

Mermaid 9 BTE

A Hearing aid intended to amplify sounds and deliver them to the ear with a microphone and Receiver housed in a behind-the-ear hardware.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• All classifications of hearing loss (sensorineural, conductive, mixed)
• If the hearing loss is conductive or mixed it must be approved for amplification by a physician
• All shapes of hearing loss (flat, sloping, reverse slope, notch)
• Severity ranging from mild to severe
• German speaking
• Current hearing aid users
• Both genders
• Ages 18 and older
• Ability and willingness to sign the consent form

Exclusion Criteria

• Contraindications for amplification
• Active ear disease
• Inability to follow the procedures of the study due to language problems, psychological disorders, dementia, or other cognitive problems of the participant
• A reduced mobility making them unable to attend weekly study appointments
• Uncooperative so that it is not possible to record a valid pure tone audiogram
• A strongly reduced dexterity
• Central hearing disorders
• Bernafon employees
• Family members of Bernafon employees

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bernafon AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barbara Simon, AuD

Role: PRINCIPAL_INVESTIGATOR

Bernafon AG

Locations

Bernafon AG

Bern, , Switzerland

Countries

Switzerland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

BF003-1808

Identifier Type: -

Identifier Source: org_study_id