A Comparative Clinical Investigation of Two Hearing Instrument Digital Signal Processing
- Conditions
- Hearing Loss
- Interventions
- Device: Polaris miniRITE BTEDevice: Viron miniRiTE BTE
- Registration Number
- NCT04374851
- Lead Sponsor
- Bernafon AG
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description New Device Polaris miniRITE BTE The new Hearing aid is essentially the same as the current device (i.e., hardware, use) but with an improved digital signal processing (DSP). Current Device Viron miniRiTE BTE 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.
- Primary Outcome Measures
Name Time Method Speech perception with narrowband noise Week 3 Speech perception is tested using a standardized speech test that requires subjects to repeat sentences presented among narrowband background noise. The test is adaptive with the background noise getting louder or softer so that the subject answers 50% correct. The scores are measured in dB SNR (signal-to-noise ratio) and a lower score is better. The lowest possible score is -15 dB SNR and the highest is +20 dB SNR. It is measured in the aided condition with the new device or the current device depending on the randomization.
- Secondary Outcome Measures
Name Time Method Acceptance of noise Week 3 Acceptance of noise is tested using a standardized noise test that requires the subjects to adjust the background noise to the maximum Levels that they can tolerate it and to the Levels at which they can understand speech. It is measured in dB SNR (signal-to-noise ratio) and a lower score is better. The lowest score possible is -25 dB SNR and the highest is +20 dB SNR. It is measured in the aided condition with the new device or the current device depending on the randomization.
Speech perception with broadband noise Week 3 Speech perception is tested using a standardized speech test that requires subjects to repeat sentences presented among broadband background noise. The test is adaptive with the background noise getting louder or softer so that the subject answers 50% correct. The scores are measured in dB SNR (signal-to-noise ratio) and a lower score is better. The lowest possible score is -15 dB SNR and the highest is +20 dB SNR. It is measured in the aided condition with the new device or the current device depending on the randomization.
Trial Locations
- Locations (1)
Bernafon AG
🇨ðŸ‡Bern, Switzerland