NCT05054816

Brief Summary

Listeners will conduct sound quality ratings of recordings talkers in a moving car processed using three different microphone processing strategies: an investigational adaptive directional microphone, an omnidirectional microphone and a fixed directional microphone. Participants will listen to the recordings streamed via commercially-available and individually-prescribed hearing aids, and conduct ratings onsite in the lab. The procedure will involve a training session and within-subject repeated measures. Stimuli will be randomized.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 23, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

February 11, 2022

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2022

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

August 17, 2025

Completed
Last Updated

August 17, 2025

Status Verified

September 1, 2021

Enrollment Period

28 days

First QC Date

September 14, 2021

Results QC Date

February 10, 2023

Last Update Submit

July 28, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • Speech Clarity

    The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Participants will be instructed to "Please rate the clarity of speech". Speech clarity ratings will be measured on a 100-point continuous slider from worst to best (0-Very unclear, 25- Unclear, 50-Slightly clear, 75-Clear, 100-Very clear). Speech clarity ratings are expected to be impacted by how intelligible the speech is. Participants will rate and compare speech clarity between the investigational and comparator features.

    Up to 6 hours over 3 2-hour sessions

  • Noise Annoyance

    The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Participants will be instructed to "Please rate how annoying the noise is". Noise annoyance ratings will be measured on a 100-point continuous slider from worst to best (0- Extremely annoying, 25-Very annoying, 50-Moderately annoying, 75-Slightly annoying, 100-Not at all annoying). Noise annoyance ratings are expected to be impacted by how bothersome the background noise in the recordings is. Participants will rate and compare noise annoyance between the investigational and comparator features.

    Up to 6 hours over 3 2-hour sessions

  • Spatialization

    The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Participants will be instructed to "Please rate your confidence that the talker is in \[a location\]", with the local being either passenger of rear left. Spatialization ratings will be measured on a 100-point continuous slider from worst to best (0-I don't know where the talker is, 25-The talker might be to my \[location\], 50-The talker is probably to my \[location\], 75-The talker is to my \[location\], 100-The talker is definitely to my \[location\]). Spatialization ratings are expected to be impacted by how well the recordings preserve spatial perception. Participants will rate and compare spatialization between the investigational and comparator features.

    Up to 6 hours over 3 2-hour sessions

  • Transition Annoyance

    The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Participants will be instructed to "Please rate how annoying the transitions are". Transitions annoyance ratings will be measured on a 100-point continuous slider from worst to best (0-Extremely annoying, 25-Very annoying, 50-Moderately annoying, 75-Slightly annoying, 100-Not at all annoying). Transition annoyance ratings are expected to be influenced by presence of unexpected sounds or transitions that occur in different microphone modes and different listening situations. Participants will rate and compare transition annoyance between the investigational and comparator features.

    Up to 6 hours over 3 2-hour sessions

  • Overall Impression

    The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Participants will be instructed to "All things considered, please rate overall preferences". Overall preferences ratings will be measured on a 100-point continuous slider from worst to best (0-Bad, 25-Poor, 50-Fair, 75-Good, 100-Excellent). Overall impression ratings are expected to be impacted by participants' overall preferences for the different stimuli. Participants will rate and compare overall impression between the investigational and comparator features.

    Up to 6 hours over 3 2-hour sessions

Study Arms (1)

Participants with hearing loss.

EXPERIMENTAL

Participants with hearing loss.

Device: Investigational adaptive directional microphone strategyDevice: Comparator omnidirectional microphone strategyDevice: Comparator fixed directional microphone strategy

Interventions

A receiver-in-canal hearing aid developed by the Study Sponsor used with the investigational adaptive directional microphone strategy that is expected to improve sound quality of speech in a car.

Participants with hearing loss.

A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator omnidirectional microphone strategy that is used with the default settings as specified in the manufacturer's fitting software.

Participants with hearing loss.

A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator fixed directional microphone strategy that is used with the default settings as specified in the manufacturer's fitting software.

Participants with hearing loss.

Eligibility Criteria

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

You may qualify if:

  • Adults (18-99 years) with ≥3 months hearing aid experience
  • binaural, symmetric, sensorineural N2 (mild) to N5 (severe) hearing loss
  • fluent in English

You may not qualify if:

  • children/teenagers
  • normal hearing or hearing loss exceeding N5 (severe) by 10 dB

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sonova Innovation Centre Toronto

Mississauga, Ontario, L5L1J3, Canada

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Jinyu Qian, PhD; VP Sonova Innovation Centre Toronto
Organization
Sonova Canada

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Hearing aid processing settings are randomized and double blinded.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A single cohort of participants will receive and be assessed in all treatment/intervention
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2021

First Posted

September 23, 2021

Study Start

February 11, 2022

Primary Completion

March 11, 2022

Study Completion

March 11, 2022

Last Updated

August 17, 2025

Results First Posted

August 17, 2025

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations