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Clinical Trials/NCT05561335
NCT05561335
Recruiting
Not Applicable

Comparison of a Novel Algorithm to a Standard Microphone Configuration for Hearing Preference

Sonova AG1 site in 1 country20 target enrollmentMarch 21, 2023
ConditionsHearing Loss

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hearing Loss
Sponsor
Sonova AG
Enrollment
20
Locations
1
Primary Endpoint
Overall preference for a specific microphone setting/configuration
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Twenty people with hearing impairment will be tested and fitted binaurally with hearing aids. During a real-world listening situation, each participant will be asked to compare one program with a novel algorithm to one with a standard microphone configuration. They will provide ratings on a range of outcome measures including overall preference and awareness of background noise. Overall and specific preferences for the different programs/algorithms will be determined by their subjective responses to determine if there is a significant difference between the two programs.

Detailed Description

People with hearing loss/impairment often have difficulty not only hearing certain sounds (e.g., environmental and speech sounds) but also listening in certain situations such as those where noise competes with speech. This is a common situation in people's real life conversations and one which different hearing instrument algorithms could facilitate. This study will investigate the listening preferences of people with hearing impairment while wearing hearing aids. They will listen to speech in a situation which is commonly reported as difficult for people who wear hearing aids. Participants will wear one set of hearing aids set to their hearing loss with two programs providing these different algorithms. By having the participants toggle (with a remote control) back and forth between algorithms designed for these real-life difficult listening situations, they can rate their preferences and listening experiences. Of particular interest, in addition to overall preference, are ratings of the background noise, listening effort and annoyance of artefacts.

Registry
clinicaltrials.gov
Start Date
March 21, 2023
End Date
October 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Sonova AG
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Subjects fulfilling all of the following inclusion criteria are eligible for the investigation:
  • Including adults with sensorineural mild to moderate-severe hearing loss
  • hearing aid experience (greater than 6 months)
  • who are able to complete the task in English.
  • Language: Can speak and understand English Fluently
  • Hearing loss within the fitting ranges of the investigational products.
  • Healthy outer ear.
  • Ability to understand instructions.
  • Ability to describe listening experiences.
  • Ability to fill out questionnaires.

Exclusion Criteria

  • The presence of any one of the following exclusion criteria will lead to the exclusion of the subject:
  • Contraindications to the MD in this study (e.g. known hypersensitivity or allergy to the investigational product).
  • Limited mobility and not able to attend to appointments or not able to go in a car.
  • Reported symptoms of vertigo and dizziness by subject.
  • Severe Tinnitus

Outcomes

Primary Outcomes

Overall preference for a specific microphone setting/configuration

Time Frame: 20 minutes

Rating of preference on a scale from 0-100, with descriptors ('very low' to 'very high')

Secondary Outcomes

  • Rating of awareness of background noise(20 minutes)
  • Rating of annoyance of artefacts(20 minutes)
  • Rating of Listening effort(20 minutes)

Study Sites (1)

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