A Comparative Clinical Investigation of Two Hearing Instrument Digital Signal Processing

Bernafon

Status: Completed

Conditions: Hearing Loss

Treatments: Device: Viron miniRiTE BTE; Device: Polaris miniRITE BTE

Study type: Interventional

Funder types: Industry

Identifiers

NCT04374851

BF005-2000

Details and patient eligibility

About

The purpose of this study is to show that the performance of the new digital signal processing system is better than the system used in the currently CE marked devices. Speech in narrowband noise and acceptable levels of noise should be improved with the new system, and speech understanding overall should not be negatively affected. There should be no artefacts or unwanted noises caused by the new system.

Full description

This is a controlled, double-blinded, comparative clinical evaluation conducted monocentric at the premised of Bernafon AG in Bern, Switzerland.

For this study, Bernafon AG will carry out testing with participants with hearing loss to validate the performance of a new digital signal processing (DSP). System testing of the DSP shows an improved signal, yet it must be tested with humans to be sure of an improvement in real-life situations. The current study will compare the new DSP to the one that is used in the Bernafon hearing aids that are CE- marked and currently available on the market. The goal is to determine whether the new DSP is better in real-life situations than the current system.

Primary Endpoint: The primary objective is to assess the new DSP system with various hearing losses and levels of amplification. Speech testing will be used to analyse the speech perception of participants.

Secondary Endpoint: The secondary objective is to verify the overall performance of the new device. Acceptable noise levels will be measured as well as further speech testing. Questionnaires will be used to measure subjective responses to the performance.

Other Endpoints: The subjective performance of an optimized fitting versus a standard fitting and the acceptance of new domes will be measured with questionnaires.

Safety Endpoint: The study aims to identify any new risk factors and to ensure the safety of the device with the newly implemented DSP system before releasing it to the market.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Hearing loss (sensorineural, conductive, mixed-must have doctor approval for mixed and conductive Hearing loss)
• Severity of Hearing loss ranging from mild to profound
• German speaking
• Current Hearing aid users
• Ability and willingness to sign the consent form

Exclusion criteria

• Contraindications for amplification
• New Hearing aid users
• Inability to follow the procedures
• Inability to attend Weekly study Appointments
• Strongly reduced dexterity
• Central Hearing disorders
• Bernafon employees
• Family members of Bernafon employees

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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19 participants in 2 patient groups

New Device

Experimental group

Description:

The new Hearing aid is essentially the same as the current device (i.e., hardware, use) but with an improved digital signal processing (DSP).

Treatment:

Device: Polaris miniRITE BTE

Current Device

Active Comparator group

Description:

The current device is the Hearing aid that is currently sold on the market. It is used as a normal Hearing aid that is worn daily to amplify sounds for Hearing-impaired people.

Treatment:

Device: Viron miniRiTE BTE