Hearing LossNCT05054816

Speech Locator In-car Performance Evaluation

A study testing Investigational adaptive directional microphone strategy, Comparator omnidirectional microphone strategy and Comparator fixed directional microphone strategy in people with Hearing Loss, run by Sonova AG at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Hearing Loss
What is being tested?: Investigational adaptive directional microphone strategy, Comparator omnidirectional microphone strategy and Comparator fixed directional microphone strategy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteCanada
Study dates: 11 Feb 2022to 11 Mar 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

Sonova Innovation Centre Toronto
Mississauga, Ontario, L5L1J3

Other trials in Canada

About this study

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.

Conditions: Hearing Loss
Being tested: Investigational adaptive directional microphone strategy, Comparator omnidirectional microphone strategy, Comparator fixed directional microphone strategy
Medical subject headings: Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Investigational adaptive directional microphone strategyDevice
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.
Comparator omnidirectional microphone strategyDevice
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.
Comparator fixed directional microphone strategyDevice
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.

Study groups in NCT05054816
Study group	Role	What they receive
Participants with hearing loss.	Experimental	Participants with hearing loss. Receives: Device: Investigational adaptive directional microphone strategy; Device: Comparator omnidirectional microphone strategy; Device: Comparator fixed directional microphone strategy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 6 hours over 3 2-hour sessions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Feb 202211 Mar 2022

First posted23 Sep 2021
Study start11 Feb 2022
Primary completion11 Mar 2022
Study completion11 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hearing LossStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: A single cohort of participants will receive and be assessed in all treatment/intervention
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05054816
Sponsor's protocol ID: SRF-459
Status last verified: Sep 2021
First submitted: 14 Sep 2021
Last updated: 17 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
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Not yet recruitingPhase 1/2
A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
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Recruiting
Assessing Pharmacy Technician Educational Training for the Provision of Over-the-Counter Hearing Aids in Rural Alabama and Mississippi Pharmacies
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All Hearing Loss trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Speech Locator In-car Performance Evaluation
ClinicalTrials.gov ID: NCT05054816
Acronym / sponsor ID: SRF-459
Conditions: Hearing Loss
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Sonova AGIndustry (pharma, biotech, devices)
Collaborators: Sonova Canada Inc.
Study start: 11 Feb 2022 (actual)
Primary completion: 11 Mar 2022 (actual)
Study completion: 11 Mar 2022 (actual)
First posted: 23 Sep 2021 (actual)
Results: Posted 17 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: A single cohort of participants will receive and be assessed in all treatment/intervention

Arm	Type	Receives
Participants with hearing loss.	Experimental	Device: Investigational adaptive directional microphone strategy, Device: Comparator omnidirectional microphone strategy, Device: Comparator fixed directional microphone strategyParticipants with hearing loss.

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Investigational adaptive directional microphone strategyA 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.	Device	Participants with hearing loss.
Comparator omnidirectional microphone strategyA 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.	Device	Participants with hearing loss.
Comparator fixed directional microphone strategyA 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.	Device	Participants with hearing loss.

Primary outcome

Speech Clarity
Time frame: Up to 6 hours over 3 2-hour sessions
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.
Noise Annoyance
Time frame: Up to 6 hours over 3 2-hour sessions
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.
Spatialization
Time frame: Up to 6 hours over 3 2-hour sessions
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.
Transition Annoyance
Time frame: Up to 6 hours over 3 2-hour sessions
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.
Overall Impression
Time frame: Up to 6 hours over 3 2-hour sessions
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.

Results and safety

Results posted to the registry on 17 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants With Hearing Loss	20	20

Primary outcome: Speech Clarity

Time frame: Up to 6 hours over 3 2-hour sessions. Mean (Standard Error). Unit: units on a scale

Measure	Participants With Hearing Loss. n = 18
Investigational adaptive directional microphone strategy	77.2 (3.7)
Comparator omnidirectional microphone strategy	76.6 (3.7)
Comparator fixed directional microphone strategy	63.6 (3.7)

Participants With Hearing Loss.: p <0.05, ANOVA

Population analysed: Two participants' data were omitted due to their results suggesting that they did not understand the task.

Primary outcome: Noise Annoyance

Time frame: Up to 6 hours over 3 2-hour sessions. Mean (Standard Error). Unit: units on a scale

Measure	Experimental: Participants With Hearing Loss. n = 18
Investigational adaptive directional microphone strategy	71.1 (3.25)
Comparator omnidirectional microphone strategy	61.4 (3.25)
Comparator fixed directional microphone strategy	60.0 (3.25)

Experimental: Participants With Hearing Loss.: p <0.05, ANOVA

Population analysed: Two participants' data were omitted due to their results suggesting that they did not understand the task.

Primary outcome: Spatialization

Time frame: Up to 6 hours over 3 2-hour sessions. Mean (Standard Error). Unit: units on a scale

Measure	Experimental: Participants With Hearing Loss. n = 18
Investigational adaptive directional microphone strategy	78.2 (6.42)
Comparator omnidirectional microphone strategy	77.7 (6.42)
Comparator fixed directional microphone strategy	50.5 (6.42)

Experimental: Participants With Hearing Loss.: p <0.05, ANOVA

Population analysed: Two participants' data were omitted due to their results suggesting that they did not understand the task.

Primary outcome: Transition Annoyance

Time frame: Up to 6 hours over 3 2-hour sessions. Mean (Standard Error). Unit: units on a scale

Measure	Experimental: Participants With Hearing Loss. n = 18
Investigational adaptive directional microphone strategy	71.7 (3.89)
Comparator omnidirectional microphone strategy	74.1 (3.89)

Experimental: Participants With Hearing Loss.: p <0.05, ANOVA

Population analysed: Two participants' data were omitted due to their results suggesting that they did not understand the task. The "fixed directional" outcome measure is not included for the transition annoyance comparator since that program does not contain transitions that can be rated and compared to the other test conditions.

Adverse events

Time frame: Adverse event data were recorded over the course of a single 2-hour study session.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Participants With Hearing Loss.	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Hearing Loss

Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Enrolling by invitation
Self-monitoring of Hearing Aids Using Artificial Intelligence
Hearing Loss
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus
Not yet recruitingPhase 1/2
A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
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Recruiting
Assessing Pharmacy Technician Educational Training for the Provision of Over-the-Counter Hearing Aids in Rural Alabama and Mississippi Pharmacies
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Speech Clarity (time frame: Up to 6 hours over 3 2-hour sessions). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05054816.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.