NCT05561335

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 30, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

March 21, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

7 months

First QC Date

September 27, 2022

Last Update Submit

September 6, 2023

Conditions

Hearing Loss

Outcome Measures

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')

    20 minutes

Secondary Outcomes (3)

  • Rating of awareness of background noise

    20 minutes

  • Rating of Listening effort

    20 minutes

  • Rating of annoyance of artefacts

    20 minutes

Study Arms (1)

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

EXPERIMENTAL

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 programDevice: hearing aid - standard program

Interventions

hearing aid -novel programDEVICE

novel microphone configuration

Hearing Aid use for listening to speech in a common difficult situation
hearing aid - standard programDEVICE

standard microphone configuration

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

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western University

London, Ontario, N6G 1G9, Canada

RECRUITING

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Susan Scollie, PhD

    Western University (aka The University of Western Ontario)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Don Hayes, PhD

CONTACT

519 500 3618don.hayes@unitron.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2022

First Posted

September 30, 2022

Study Start

March 21, 2023

Primary Completion

October 31, 2023

Study Completion

October 31, 2023

Last Updated

September 7, 2023

Record last verified: 2023-09

Locations

CA(1)