Prototype Device for Hearing Loss in Infants
(SEFR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a newly developed prototype device that measures how infant brains respond to speech sounds. Researchers aim to determine if the device can detect differences in brain responses between infants with hearing loss and those with normal hearing, both with and without hearing aids. It suits infants aged 3 to 24 months who have either normal hearing or hearing loss and have been fitted with hearing aids. The study involves up to two sessions where the device records brain responses to speech sounds. As an unphased trial, this study offers a unique opportunity for infants to contribute to groundbreaking research that could enhance early detection and intervention for hearing loss.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
What prior data suggests that this prototype device is safe for infants?
Research shows that the new device for measuring brain responses in infants is a unique tool for checking hearing. Although specific safety data for this device is unavailable, hearing assessment tools for infants are generally considered low-risk. These tools are usually non-invasive, meaning they don't enter the body or cause harm.
In this trial, the device measures how infants' brains react to sounds without altering any hearing aid settings. This involves recording responses during one or two sessions. Since the device only records, it likely poses minimal risk to participants.
While specific safety studies on this device are lacking, similar devices used for infant hearing tests have proven safe and well-tolerated. Overall, hearing assessment tools for infants have a strong safety record, suggesting that this new device should be safe for use in the trial.12345Why are researchers excited about this trial?
Researchers are excited about the newly developed prototype device for hearing loss in infants because it offers a novel way to assess and potentially aid hearing in infants who are too young for traditional hearing tests. Unlike typical hearing aids and cochlear implants, which are standard treatments for hearing loss and require fitting and surgical procedures, this device uses speech-evoked envelope following responses (EFRs) to evaluate and support hearing responses in both normal and hearing-impaired infants. This non-invasive approach could provide a quicker, more accurate assessment of an infant's hearing capabilities and help tailor more effective interventions early on, possibly improving long-term auditory outcomes.
What evidence suggests that this prototype device is effective for measuring brain responses to speech sounds in infants with hearing loss?
This trial tests a newly developed prototype device designed to measure how infants' brains respond to speech sounds. The device aims to differentiate between brain responses in infants with normal hearing and those with hearing loss. Early results suggest that similar devices, which use technology to detect hearing problems in infants, have proven accurate and effective. Previous studies have shown that these devices can reliably identify hearing loss by analyzing infants' responses to sound. This method could help detect hearing issues early, allowing for timely treatment.26789
Who Is on the Research Team?
Susan Scollie, PhD
Principal Investigator
Western University
David Purcell, PhD
Principal Investigator
Western University
Are You a Good Fit for This Trial?
This trial is for infants with and without hearing loss to test a new device that measures brain responses to speech sounds. Infants must be able to attend 1-2 sessions, and those with hearing aids will have additional tests. Specific inclusion or exclusion criteria are not provided.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Recording Session
Participants undergo recording sessions of speech-evoked envelope following responses (EFRs) using the prototype device
Follow-up Recording Session
If required, a second recording session is conducted to complete outcome data collection
Follow-up
Participants are monitored for safety and effectiveness after recording sessions
What Are the Treatments Tested in This Trial?
Interventions
- Newly Developed Prototype Device
Trial Overview
Researchers are testing a prototype device designed to measure how the brains of infants respond to speech sounds. They want to see if it works differently for babies with normal hearing versus those with hearing loss, both with and without their hearing aids.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Infants 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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Susan Scollie
Lead Sponsor
Dalhousie University
Collaborator
Citations
Evaluation of the Design and Development of the HeLe ... - PMC
As a novel technology-based NHS system, HeLe is a potentially powerful tool to assist in monitoring newborn hearing disease caseloads by community-based primary ...
Preventing Childhood Hearing Loss Worldwide
Local and global collaborations help BME Design Fellows make a low-cost, affordable, and easy-to-use screening tool for hearing loss in children.
new newborn hearing screening device
The open-source device uses a smartphone and low-cost earbuds to determine whether a baby has hearing loss. Test results show it's an accurate, affordable ...
Program Connects Deaf or Hard of Hearing Infants and ...
The Department of Health and Human Services has a program that tracks infants' screening for and diagnosis of hearing loss.
5.
hearingreview.com
hearingreview.com/hearing-products/accessories/components/new-developments-in-fitting-software-for-childrenNew Developments in Fitting Software for Children
Evidence-based customizable software has been developed for accurate, efficient, holistic pediatric hearing aid fittings. It is crucial when fitting children to ...
6.
umdearborn.edu
umdearborn.edu/news/new-medical-device-could-help-diagnose-infants-vestibular-issuesA new medical device could help diagnose infants with ...
Designed and built by students, faculty and staff from UM-Dearborn, a rotational chair for infants could make screening for vestibular issues as ...
Evaluation of safety and effectiveness of the LISTENT LCI ...
The new developed LCI-20PI CI device proved safe and effective in prelingually deafened children (<6 years old) in the clinical trial.
8.
journals.lww.com
journals.lww.com/ear-hearing/fulltext/9900/evaluation_of_a_totally_implantable_cochlear.514.aspxEvaluation of a Totally Implantable Cochlear Implant in...
The aim of the present study was to investigate the efficacy, safety, and patient-reported outcomes of the TICI Research System in both the EH ...
9.
mccormick.northwestern.edu
mccormick.northwestern.edu/news/articles/2025/12/qsi-teams-to-fast-track-medical-device-development/QSI-TEAMS to Fast-Track Medical Device Development | News
“Our smart wearable aims to help individuals prevent vocal fatigue and injury while also opening new possibilities for clinical voice care and ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.