A Comparative Clinical Investigation of Two Hearing Instrument Digital Signal Processing

A Comparative Clinical Investigation of Two Hearing Instrument Digital Signal Processing Strategies and Their Effect on Speech Understanding

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: Polaris miniRITE BTE; Device: Viron miniRiTE BTE

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3018
    • Bernafon AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: New Device; The new Hearing aid is essentially the same as the current device (i.e., hardware, use) but with an improved digital signal processing (DSP).	Device: Polaris miniRITE BTE; The Polaris device is programmed with computer software to match the Hearing loss of the participant.
ACTIVE_COMPARATOR: Current Device; 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.	Device: Viron miniRiTE BTE; The Viron Hearing device is programmed with computer software to match the Hearing loss of the participant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech perception with narrowband noise	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 unaided condition.	Week 1
Speech perception with narrowband noise	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.	Week 2
Speech perception with narrowband noise	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.	Week 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech perception with broadband noise	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 unaided condition.	Week 1
Speech perception with broadband noise	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.	Week 2
Speech perception with broadband noise	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.	Week 3
Acceptance of noise	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 unaided condition.	Week 1
Acceptance of noise	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.	Week 2
Acceptance of noise	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.	Week 3

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preference for Standard or Optimized Fitting	The Hearing aids will be programmed with a standard or default Fitting from the software and with an optimized Fitting based on questions answered by the subjects. At the end of a field test using both Fittings they will answer a questionnaire asking them to choose a preferred Fitting. They will have a scale from 1 to 10 to say how sure they are about their choice (1 being unsure and 10 being completely sure). They will also choose from a list of options reasons for giving their choice (i.e., speech intelligibility, Sound Quality, feedback).	Week 5

Collaborators and Investigators

• Sponsor: Bernafon AG

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 3, 2020
• Primary Completion (ACTUAL): November 30, 2020
• Study Completion (ACTUAL): November 30, 2020

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: May 1, 2020
• First Posted (ACTUAL): May 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 7, 2021
• Last Update Submitted That Met QC Criteria: January 6, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: BF005-2000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No