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RecruitingNCT05561335Updated Sep 7, 2023

Preference Comparisons for Algorithms to Hear Speech

An interventional study of hearing aid -novel program and hearing aid - standard program in Hearing Loss, sponsored by Sonova AG. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-07.

Sponsored by Sonova AG · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hearing Loss

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03

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.
  • Informed consent as documented by signature.

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Hearing Aid use for listening to speech in a common difficult situation

    The hearing aids will be worn in two different programs, each with a different microphone configuration. The participants will listen to speech while wearing the hearing aids and alternate programs to form their opinions about these programs; they will only know that they are rating different settings, not what the settings are. They will then rate their listening experiences via rating scales to determine their preferences.

    Device: hearing aid -novel program · Device: hearing aid - standard program

Interventions

  • Devicehearing aid -novel program

    novel microphone configuration

  • Devicehearing aid - standard program

    standard microphone configuration

05

What researchers measure

Primary outcomes

  1. Overall preference for a specific microphone setting/configuration

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

    Time frame: 20 minutes

Secondary outcomes

  1. Rating of awareness of background noise

    Scale from 0-100 with descriptors ('not at all' to 'extremely aware')

    Time frame: 20 minutes

  2. Rating of Listening effort

    Scale from 1 - 7 with descriptors ('not at all' to 'very')

    Time frame: 20 minutes

  3. Rating of annoyance of artefacts

    Rating on a scale from 0-100 with descriptors ('not at all' to 'extremely annoying')

    Time frame: 20 minutes

06

Study locations

1 of 1 sites recruiting
  • Western University
    London, Ontario N6G 1G9, Canada
    Recruiting
07

Registry details

Key details

Study ID
NCT05561335
Lead sponsor
Sonova AG
Collaborators
Western University
Responsible party
Sponsor
First posted
Sep 30, 2022
Start date
Mar 21, 2023
Primary completion
Oct 31, 2023 (estimated)
Completion
Oct 31, 2023 (estimated)
Last update
Sep 7, 2023

Study contacts

Don Hayes, PhD
Contact
don.hayes@unitron.com
519 500 3618
Susan Scollie, PhD
principal investigator · Western University (aka The University of Western Ontario)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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