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Completed

NCT Number: NCT04374851

A Comparative Clinical Investigation of Two Hearing Instrument Digital Signal Processing

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.

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bernafon AG

Bern, 3018, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polaris miniRITE BTE

Device

The Polaris device is programmed with computer software to match the Hearing loss of the participant.

Viron miniRiTE BTE

Device

The Viron Hearing device is programmed with computer software to match the Hearing loss of the participant.

Primary outcomes

  1. Speech perception with narrowband noise

    Time frame: Week 1

    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.

  2. Speech perception with narrowband noise

    Time frame: Week 2

    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.

  3. Speech perception with narrowband noise

    Time frame: 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 outcomes

  1. Speech perception with broadband noise

    Time frame: Week 1

    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.

  2. Speech perception with broadband noise

    Time frame: Week 2

    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.

  3. Speech perception with broadband noise

    Time frame: 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.

  4. Acceptance of noise

    Time frame: Week 1

    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.

  5. Acceptance of noise

    Time frame: Week 2

    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.

  6. Acceptance of noise

    Time frame: 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.

Other outcomes

  1. Preference for Standard or Optimized Fitting

    Time frame: Week 5

    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).

Sponsors and collaborators

Lead sponsor

Bernafon AG

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 5, 2020
Registry last updated
Jan 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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