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Compression Headphone Study

Using Headphone Presentation to Investigate Compression Strategy Modifications in Hearing Aids for Moderate-to-severe Hearing Loss

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04882709
Enrollment
12
Registered
2021-05-12
Start date
2021-05-10
Completion date
2021-09-02
Last updated
2025-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss

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.

Interventions

DEVICERecording with hearing aid

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.

Sponsors

Sonova Canada Inc.
CollaboratorINDUSTRY
Sonova AG
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Sound Quality Rating1 hourParticipants 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).

Countries

Canada

Participant flow

Participants by arm

ArmCount
Complete Sample
Each participant will listen to sound samples via headphones. Sound samples have been recorded with each of the devices listed under intervention which were set to each participant's individual hearing loss, and an unaided reference. Participants will be asked to rate different aspects of sound quality while listening to the different sound samples.
11
Total11

Baseline characteristics

CharacteristicComplete Sample
Age, Continuous68 years
STANDARD_DEVIATION 13
Good cognitive abilities11 Participants
Hearing aid experience17 years
STANDARD_DEVIATION 10
Hearing loss11 Participants
Normal or corrected to normal vision11 Participants
Race and Ethnicity Not Collected— Participants
Sex: Female, Male
Female
7 Participants
Sex: Female, Male
Male
4 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 12
other
Total, other adverse events
0 / 12
serious
Total, serious adverse events
0 / 12

Outcome results

Primary

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).

Time frame: 1 hour

Population: The median and IQR is presented for each sound quality dimension (Reverberation, Sound Source Separation, Sound Source Location and Overall) in sound scene (speech in quiet, speech in noise, speech in reverberance, music).

ArmMeasureGroupValue (MEDIAN)
Hearing Aid 1 Default Amplification StrategySound Quality RatingSound source separation in speech in quiet62.5 units on a scale
Hearing Aid 1 Default Amplification StrategySound Quality RatingOverall Preference for speech in noise3.5 units on a scale
Hearing Aid 1 Default Amplification StrategySound Quality RatingSound source separation in music65.5 units on a scale
Hearing Aid 1 Default Amplification StrategySound Quality RatingOverall Preference for speech in quiet3.5 units on a scale
Hearing Aid 1 Default Amplification StrategySound Quality RatingOverall Preference for reverberant speech3 units on a scale
Hearing Aid 1 Default Amplification StrategySound Quality RatingSound source location in speech in quiet59 units on a scale
Hearing Aid 1 Default Amplification StrategySound Quality RatingReverberation in reverberant speech56.5 units on a scale
Hearing Aid 1 Default Amplification StrategySound Quality RatingSound source separation in speech in noise55 units on a scale
Hearing Aid 1 Default Amplification StrategySound Quality RatingReverberation in speech in quiet69 units on a scale
Hearing Aid 1 Default Amplification StrategySound Quality RatingSound source localization in reverberant speech45.5 units on a scale
Hearing Aid 1 Default Amplification StrategySound Quality RatingOverall Preference for music3 units on a scale
Hearing Aid 1 Default Amplification StrategySound Quality RatingSound source location in speech in noise74 units on a scale
Hearing Aid 1 Default Amplification StrategySound Quality RatingSound source separation in reverberant speech50 units on a scale
Hearing Aid 1 Default Amplification StrategySound Quality RatingSound source localization in music60.5 units on a scale
Hearing Aid 2Sound Quality RatingSound source separation in reverberant speech61 units on a scale
Hearing Aid 2Sound Quality RatingOverall Preference for speech in noise3.5 units on a scale
Hearing Aid 2Sound Quality RatingSound source separation in music71.5 units on a scale
Hearing Aid 2Sound Quality RatingOverall Preference for speech in quiet3.5 units on a scale
Hearing Aid 2Sound Quality RatingSound source localization in music69.5 units on a scale
Hearing Aid 2Sound Quality RatingSound source location in speech in quiet50.5 units on a scale
Hearing Aid 2Sound Quality RatingReverberation in reverberant speech54.5 units on a scale
Hearing Aid 2Sound Quality RatingSound source localization in reverberant speech56 units on a scale
Hearing Aid 2Sound Quality RatingSound source separation in speech in quiet59 units on a scale
Hearing Aid 2Sound Quality RatingReverberation in speech in quiet55 units on a scale
Hearing Aid 2Sound Quality RatingOverall Preference for music3 units on a scale
Hearing Aid 2Sound Quality RatingSound source separation in speech in noise52 units on a scale
Hearing Aid 2Sound Quality RatingOverall Preference for reverberant speech3 units on a scale
Hearing Aid 2Sound Quality RatingSound source location in speech in noise63 units on a scale
Hearing Aid 1 Strategy 1Sound Quality RatingOverall Preference for music3.5 units on a scale
Hearing Aid 1 Strategy 1Sound Quality RatingReverberation in speech in quiet71 units on a scale
Hearing Aid 1 Strategy 1Sound Quality RatingSound source localization in reverberant speech69.5 units on a scale
Hearing Aid 1 Strategy 1Sound Quality RatingSound source localization in music66.5 units on a scale
Hearing Aid 1 Strategy 1Sound Quality RatingReverberation in reverberant speech70 units on a scale
Hearing Aid 1 Strategy 1Sound Quality RatingSound source separation in speech in quiet59.5 units on a scale
Hearing Aid 1 Strategy 1Sound Quality RatingSound source separation in speech in noise70 units on a scale
Hearing Aid 1 Strategy 1Sound Quality RatingSound source separation in reverberant speech61 units on a scale
Hearing Aid 1 Strategy 1Sound Quality RatingSound source separation in music68.5 units on a scale
Hearing Aid 1 Strategy 1Sound Quality RatingOverall Preference for speech in quiet3.5 units on a scale
Hearing Aid 1 Strategy 1Sound Quality RatingOverall Preference for speech in noise3.5 units on a scale
Hearing Aid 1 Strategy 1Sound Quality RatingOverall Preference for reverberant speech4 units on a scale
Hearing Aid 1 Strategy 1Sound Quality RatingSound source location in speech in quiet61.5 units on a scale
Hearing Aid 1 Strategy 1Sound Quality RatingSound source location in speech in noise65 units on a scale
Hearing Aid 1 Strategy 2Sound Quality RatingSound source separation in music79.5 units on a scale
Hearing Aid 1 Strategy 2Sound Quality RatingSound source location in speech in noise61 units on a scale
Hearing Aid 1 Strategy 2Sound Quality RatingOverall Preference for speech in noise3 units on a scale
Hearing Aid 1 Strategy 2Sound Quality RatingSound source separation in reverberant speech61 units on a scale
Hearing Aid 1 Strategy 2Sound Quality RatingOverall Preference for reverberant speech3.5 units on a scale
Hearing Aid 1 Strategy 2Sound Quality RatingSound source separation in speech in noise64.5 units on a scale
Hearing Aid 1 Strategy 2Sound Quality RatingOverall Preference for music4 units on a scale
Hearing Aid 1 Strategy 2Sound Quality RatingReverberation in reverberant speech70.5 units on a scale
Hearing Aid 1 Strategy 2Sound Quality RatingSound source separation in speech in quiet69 units on a scale
Hearing Aid 1 Strategy 2Sound Quality RatingSound source localization in reverberant speech55.5 units on a scale
Hearing Aid 1 Strategy 2Sound Quality RatingSound source location in speech in quiet55 units on a scale
Hearing Aid 1 Strategy 2Sound Quality RatingSound source localization in music67.5 units on a scale
Hearing Aid 1 Strategy 2Sound Quality RatingReverberation in speech in quiet80 units on a scale
Hearing Aid 1 Strategy 2Sound Quality RatingOverall Preference for speech in quiet4 units on a scale
UnaidedSound Quality RatingSound source separation in reverberant speech39 units on a scale
UnaidedSound Quality RatingReverberation in reverberant speech40.5 units on a scale
UnaidedSound Quality RatingSound source localization in reverberant speech49 units on a scale
UnaidedSound Quality RatingOverall Preference for speech in noise1 units on a scale
UnaidedSound Quality RatingSound source localization in music44 units on a scale
UnaidedSound Quality RatingSound source separation in speech in noise30 units on a scale
UnaidedSound Quality RatingSound source location in speech in noise43.5 units on a scale
UnaidedSound Quality RatingSound source separation in music30 units on a scale
UnaidedSound Quality RatingOverall Preference for reverberant speech3 units on a scale
UnaidedSound Quality RatingOverall Preference for speech in quiet1 units on a scale
UnaidedSound Quality RatingSound source separation in speech in quiet29 units on a scale
UnaidedSound Quality RatingReverberation in speech in quiet42 units on a scale
UnaidedSound Quality RatingSound source location in speech in quiet25 units on a scale
UnaidedSound Quality RatingOverall Preference for music1 units on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026