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Hearing ImpairmentSEFRNCT07392164

Speech-Evoked Auditory Potentials: Multisite Pediatric Evaluation

A study testing A newly developed prototype device for speech-evoked EFR Measurement in people with Hearing Impairment, run by Susan Scollie at 3 sites in 2 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this study is to evaluate the sensitivity of a newly-developed prototype device in its ability to measure brain responses to speech sounds in an infant population. The main research questions are: 1) Is the prototype sensitive to brain response differences from infants with hearing loss with and without… Read more about this study

Who is it for?
Ages 3 to 24 monthsHealthy volunteers can take part
Conditions the study is for
Hearing Impairment
What is being tested?
A newly developed prototype device for speech-evoked EFR Measurement
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
3 sitesin 2 countries
Study dates
Mar 2026to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 3 to 24 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Infants (3 to 24 months of age) with normal hearing who have passed their audiological diagnostic evaluation
  • Infants (3 to 24 months of age) identified with hearing loss at their audiological diagnostic evaluation, whose parents have chosen spoken language as their form of communication, and who have been prescribed and fitted with a hearing aid(s).

Who cannot join

  • Participants who have abnormal middle ear measure results or occluding ear wax will be excluded.

Trial locations and contacts

3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Susan Scollie, PhD contact

519-661-2111 ext. 88948

scollie@nca.uwo.ca

Krystal Beh, MClSc contact

kbeh@nca.uwo.ca

3 sites in 2 countries

Canada2 sites

  • Dalhousie University

    Halifax, Nova Scotia, B3H4R2

    Steven Aiken, PhD, 902-494-7052, steve.aiken@dal.ca

    Steven Aiken, PhD

  • National Centre for Audiology at Western University

    London, Ontario, N6G1H1

    Susan Scollie, PhD, 519-661-2111 ext. 88948, scollie@nca.uwo.ca

    Susan Scollie, PhD

Other trials in Canada

Australia1 site

  • National Acoustic Laborartory

    Macquarie Park, Sydney, NSW 2113

    Viji Easwar, +61 2 9412 7026, viji.easwar@nal.gov.au

Other trials in Australia

About this study

The goal of this study is to evaluate the sensitivity of a newly-developed prototype device in its ability to measure brain responses to speech sounds in an infant population. The main research questions are: 1) Is the prototype sensitive to brain response differences from infants with hearing loss with and without hearing aids? and 2) How do the measured brain responses from infants with hearing loss compare to infants with normal hearing who are the same age? Participants will have their brain responses measured using the prototype in response to average-level non-sense speech sounds across 1 to 2 sessions in a "no-hearing aids" condition. Participants with hearing loss who are already fit with hearing aids will additionally undergo a "with hearing aids" recording condition.

Read the detailed description

In addition to the listed collaborator sites under the "sponsors and collaborators" section, this study is conducted in collaboration with the National Acoustic Laboratories (NAL), Australia, who serve as an international clinical research site contributing to data collection and scientific expertise in pediatric audiology. The prototype is being provided by Audioscan, Dorchester, ON, Canada.

Additionally, the newly developed clinical prototype device is not a U.S. FDA-regulated device. ClinicalTrials.gov registration is being completed as a prerequisite for Health Canada's investigational testing of medical devices, as outlined in Health Canada's 2007 Notice concerning registration and public disclosure of clinical trial information. The application number for Health Canada's investigational testing authorization is 389562.

Being tested
A newly developed prototype device for speech-evoked EFR Measurement
Keywords
Hearing, Hearing impairment, Hearing aids, Evoked potentials, Pediatrics
Medical subject headings
Hearing Loss

What participants receive

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

  • A newly developed prototype device for speech-evoked EFR MeasurementDevice

    Speech-evoked envelope following responses (EFRs) are measured using the newly developed clinical prototype to objectively assess auditory responses. Surface electrodes are placed on the head, a non-sense speech stimulus is presented at an average level, and EFRs are recorded for 15-30 minutes while patient sleeps or is at rest.

Study groups in NCT07392164
Study groupRoleWhat they receive
Infants with normal hearing and with hearing lossExperimentalInfants with clinically confirmed normal hearing and hearing loss. Participants will undergo up to 2 recording sessions of speech-evoked envelope following responses (EFRs) using the newly developed prototype device in both unaided (for normal hearing) and aided conditions (if child has been fit with hearing aids). If applicable, hearing aid settings will be recorded; their device settings will not be altered. Hearing assessment results and acoustic measures will be obtained through chart review with caregiver consent.
Receives: Device: A newly developed prototype device for speech-evoked EFR Measurement

What is being measured

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

  1. Speech-Evoked Envelope Following Responses (EFRs) Agreement with Hearing Assessment

    EFR detection rates will be compared to hearing assessment results for the "Infants with normal hearing" and the "Infants with hearing loss" group for the unaided recording condition. Correlation and regression analysis will be used to look at agreement between prototype measures and the child's hearing assessment results.

    Measured: Outcomes are assessed during the initial recording session (Day 1). When two sessions are required, outcome data collection is completed within 2 weeks of the first session.

Secondary outcomes (4)

  1. Speech-evoked Envelope Following Response (EFR) Amplitude in Infants with Hearing Loss

    EFR amplitudes will be compared between the aided and unaided conditions of the "Infants with hearing loss" group. Repeated measures ANOVA and post-hoc paired t-tests will be used for data analysis.

    Measured: Outcomes are assessed during the initial recording session (Day 1). When two sessions are required, outcome data collection is completed within 2 weeks of the first session.

  2. Speech-Evoked Envelope Following Responses (EFRs) Amplitude Between Normal Hearing and Hearing Loss Infants

    EFR amplitudes will be compared between the "Infants with normal hearing" and the "Infants with hearing loss" groups. EFR amplitude will also be compared between groups by deriving a normal range of measurement (from normal hearing infants) and characterizing whether measures from infants with hearing loss are or are not within that range. This is a descriptive, not inferential, analysis that is mainly used to aid in interpretation of the nature of the response, so inferential statistics are not proposed.

    Measured: Outcomes are assessed during the initial recording session (Day 1). When two sessions are required, outcome data collection is completed within 2 weeks of the first session.

  3. Speech-evoked Envelope Following Response (EFR) detection rates in Infants with Hearing Loss

    EFR detection rates will be compared between the aided and unaided conditions of the "Infants with hearing loss" group. Repeated measures ANOVA and post-hoc paired t-tests will be used for data analysis.

    Measured: Outcomes are assessed during the initial recording session (Day 1). When two sessions are required, outcome data collection is completed within 2 weeks of the first session.

  4. Speech-Evoked Envelope Following Responses (EFRs) Detection Rate Between Normal Hearing and Hearing Loss Infants

    EFR detection rate will be compared between the "Infants with normal hearing" and the "Infants with hearing loss" groups. EFR detection rate will also be compared between groups by deriving a normal range of measurement (from normal hearing infants) and characterizing whether measures from infants with hearing loss are or are not within that range. This is a descriptive, not inferential, analysis that is mainly used to aid in interpretation of the nature of the response, so inferential statistics are not proposed.

    Measured: Outcomes are assessed during the initial recording session (Day 1). When two sessions are required, outcome data collection is completed within 2 weeks of the first session.

Timeline

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

  1. First posted6 Feb 2026
  2. Study startMar 2026 (estimated)
  3. Primary completionAug 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07392164
Sponsor's protocol ID
122331
Acronym
SEFR
Status last verified
Jan 2026
First submitted
1 Dec 2025
Last updated
6 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: For the reasons of transparency and education, it is strongly encouraged by many medical journals and other authorities to publish the anonymized data from clinical studies for public use. This data is visible to researchers or the general public after the study is over. Researchers may use this data to improve knowledge about brain responses to speech sounds. We will publish the following anonymized data from this study: audiogram, middle ear analysis, speech test scores, and auditory evoked potentials. Note that there will be NO personal identifiers in this list.

Publications

  • Easwar V, Scollie S, Lasarev M, Urichuk M, Aiken SJ, Purcell DW. Characteristics of Speech-Evoked Envelope Following Responses in Infancy. Trends Hear. 2021 Jan-Dec;25:23312165211004331. doi: 10.1177/23312165211004331.

    PubMed 34251887

  • Easwar V, Purcell DW, Aiken SJ, Parsa V, Scollie SD. Evaluation of Speech-Evoked Envelope Following Responses as an Objective Aided Outcome Measure: Effect of Stimulus Level, Bandwidth, and Amplification in Adults With Hearing Loss. Ear Hear. 2015 Nov-Dec;36(6):635-52. doi: 10.1097/AUD.0000000000000199.

    PubMed 26226606

Questions about this trial

What is this clinical trial studying?

A study testing A newly developed prototype device for speech-evoked EFR Measurement in people with Hearing Impairment, run by Susan Scollie at 3 sites in 2 countries.

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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada, Australia. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Susan Scollie, PhD (519-661-2111 ext. 88948, scollie@nca.uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Speech-Evoked Envelope Following Responses (EFRs) Agreement with Hearing Assessment (time frame: Outcomes are assessed during the initial recording session (Day 1). When two sessions are required, outcome data collection is completed within 2 weeks of the first session.). 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 NCT07392164, which also lists 2 linked publications.

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 6 Feb 2026.

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