NCT04882709

Brief Summary

The stimuli consist of speech in quiet, speech in noise, reverberant speech, and music recorded with different hearing aid settings, post-processed for headphone presentation and incorporated in an online sound survey. Participants will receive tablets and headphones to conduct a sound quality rating at home. The survey will involve a training session and within-subject repeated measures. Stimuli presentation will be randomized by sound quality rating tool.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

May 4, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

May 10, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2021

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

August 13, 2025

Completed
Last Updated

August 13, 2025

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

May 4, 2021

Results QC Date

June 9, 2023

Last Update Submit

August 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sound Quality Rating

    Participants moved through a self-guided, double-blinded sound survey which presented sound samples of all hearing aid conditions (see Arms/Groups for conditions) and asked participants to rate the sound quality dimensions on a scale. The rating dimensions and scales were based on a sound quality rating guidance document by Delta Labs (Danmark) ranging from 0 to 100 with step sizes of 1 and descriptive markers at 0 (worst), 20, 40, 60, 80 and 100 (best) depending on the dimension (Reverberation (only assessed for Speech in Quiet and Reverberant Speech), Sound Source Localization, Sound Source Separation, and Timbral Balance). Overall Preference was implemented as a ranking according to the 5-point Mean Opinion Score (bad (1), poor (2), fair (3), good (4), excellent (5); MOS, International Telecommunication Union, 1996).

    1 hour

Study Arms (5)

Hearing aid 1 default amplification strategy

EXPERIMENTAL

Hearing aid 1 default amplification strategy: A receiver-in-canal (RIC) hearing aid developed by the study sponsor used with the default settings as specified in the study sponsor's fitting software.

Device: Recording with hearing aid

Hearing aid 2

EXPERIMENTAL

Hearing aid 2: A receiver-in-canal (RIC) hearing aid developed by the another hearing aid manufacturer used with the default settings as specified in the manufacturer's fitting software.

Device: Recording with hearing aid

Hearing aid 1 strategy 1

EXPERIMENTAL

Hearing aid 1 strategy 1: A receiver-in-canal (RIC) hearing aid developed by the study sponsor used with a modified compression strategy that is expected to improve sound quality.

Device: Recording with hearing aid

Hearing aid 1 strategy 2

EXPERIMENTAL

Hearing aid 1 strategy 2: A receiver-in-canal (RIC) hearing aid developed by the study sponsor used with a modified compression strategy that is expected to improve sound quality.

Device: Recording with hearing aid

unaided

NO INTERVENTION

Unaided recording to be used for normalization of rating results.

Interventions

Each participant will listen to sound samples via headphones. Sound samples have been recorded with a hearing aid that was set to each participant's individual hearing loss and different amplification strategies, and an unaided reference. Participants will be asked to rate different aspects of sound quality while listening to the different sound samples.

Hearing aid 1 default amplification strategyHearing aid 1 strategy 1Hearing aid 1 strategy 2Hearing aid 2

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 N3 to N4 hearing loss
  • able to use Android interface and receive a video call on phone/computer
  • fluent in English

You may not qualify if:

  • children/teenagers
  • normal hearing or hearing loss exceeding N4 by 10dB
  • cannot wear over-ear headphones

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

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Wearable Electronic DevicesElectrical Equipment and SuppliesEquipment and SuppliesSensory Aids

Results Point of Contact

Title
Dr. Jinyu Qian
Organization
Sonova Canada Inc.

Study Officials

  • Jinyu Qian, PhD

    Sonova Canada Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The acoustic output of the different devices had been recorded and the recordings have been presented in random order (random order created by the sound survey algorithm) to the participants in a digital sound survey, so neither the researcher nor the participant knew which recording the participant was listening to when rating.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2021

First Posted

May 12, 2021

Study Start

May 10, 2021

Primary Completion

September 2, 2021

Study Completion

September 2, 2021

Last Updated

August 13, 2025

Results First Posted

August 13, 2025

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations