Clinical trial NCT04374851: A Comparative Clinical Investigation of Two Hearing Instrument Digital Signal Processing
Official title: A Comparative Clinical Investigation of Two Hearing Instrument Digital Signal Processing Strategies and Their Effect on Speech Understanding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Bernafon AG
Sponsor class: INDUSTRY
First posted: 2020-05-05
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Subjects will randomly wear the new device or the current device for the first period and then switch to the other device for the second period.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Speech perception with narrowband noise
timeFrame: Week 1
measure: Speech perception with narrowband noise
timeFrame: Week 2
measure: Speech perception with narrowband noise
timeFrame: Week 3
Secondary outcomes:
measure: Speech perception with broadband noise
timeFrame: Week 1
measure: Speech perception with broadband noise
timeFrame: Week 2
measure: Speech perception with broadband noise
timeFrame: Week 3
measure: Acceptance of noise
timeFrame: Week 1
measure: Acceptance of noise
timeFrame: Week 2
measure: Acceptance of noise
timeFrame: Week 3
Other outcomes:
measure: Preference for Standard or Optimized Fitting
timeFrame: Week 5
Locations:
city: Bern
country: Switzerland
facility: Bernafon AG
Study officials:
affiliation: Bernafon AG
name: Barbara Simon, AuD
role: PRINCIPAL_INVESTIGATOR
References: