Flexible Conductive Hearing Aids for Conductive Hearing Loss

Overseen By Enosh Lim, MS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Cognitive impairment, unwillingness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 hour

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new flexible hearing aid for individuals with conductive hearing loss, where sound struggles to move through the outer or middle ear. The study will evaluate how this hearing aid improves hearing ability compared to current aids or no aid at all. It suits those diagnosed with conductive or mixed hearing loss, whether they already use hearing aids or are considering ear surgeries. Healthy individuals without hearing loss can also participate to help simulate the condition. As an unphased trial, participants contribute to groundbreaking research that may lead to innovative hearing solutions.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this flexible conductive hearing aid is safe for use in conductive hearing loss?

Research has shown that flexible conductive hearing aids are safe. These devices offer a non-invasive solution for conductive hearing loss. Studies have found that users generally tolerate them well, with no reports of serious side effects. Unlike hearing aids requiring implantation, these flexible ones do not need surgery, reducing potential risks. This makes them a promising choice for both children and adults with conductive hearing loss. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional hearing aids that can be bulky and uncomfortable, the Flexible Conductive Hearing Aid is designed like a Band-Aid, offering a more comfortable and discreet option for those with conductive hearing loss. This innovative device works by directly conducting sound through the skin, bypassing the damaged parts of the ear, which is a different approach compared to conventional hearing aids that amplify sound. Researchers are excited about this treatment because it promises to improve sound quality and user comfort, potentially making it a game-changer for individuals who struggle with the limitations of existing hearing aid technology.

What evidence suggests that this flexible conductive hearing aid is effective for conductive hearing loss?

Research shows that flexible conductive hearing aids, tested in this trial, can help people with conductive hearing loss hear better. These aids create vibrations on the skin to improve sound transmission, bypassing ear problems. Early studies suggest that this type of hearing aid greatly improves the ability to hear quiet sounds in both children and adults with conductive hearing loss. This noninvasive method is especially promising for children, offering a new way to manage permanent hearing loss from birth conditions like underdeveloped outer ears or ear bones. Overall, evidence supports that flexible conductive hearing aids significantly enhance hearing ability. ^{1 2 3 6 7}

Who Is on the Research Team?

Mohammad Moghimi, PhD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for pregnant women, infants, children, adolescents, and adults diagnosed with conductive or mixed hearing loss. It includes those who may already use hearing aids or are candidates for certain types of hearing aid surgery. Healthy individuals without hearing loss can also participate. Adults unable to understand the study details or unwilling to participate are excluded.

Inclusion Criteria

Pregnant women are eligible for this study. Standard of Care allows pregnant patients to be fit for hearing aids without risk.

Male and female patients seen at Atrium Health-Audiology for a clinical, standard of care office visit with a diagnosis of conductive or mixed hearing loss and may currently wear hearing aids

I have been diagnosed with a type of hearing loss in one or both ears.

Exclusion Criteria

I understand the study's purpose and am willing to participate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assessed for hearing thresholds before and during the use of the flexible Band-Aid style hearing device

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for any changes in hearing thresholds and device effectiveness after initial use

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Flexible Conductive Hearing Aid

Trial Overview The trial is evaluating a flexible conductive hearing aid designed for people with conductive hearing loss—a condition where sound doesn't move correctly from the outer ear to the cochlea—often due to congenital issues like microtia/anotia or atresia.

How Is the Trial Designed?

Group I: flexible Band-Aid style hearing device Experimental Treatment 1 Intervention

Patients with conductive/mixed hearing loss will be assessed to observe their hearing threshold before using the hearing aid and reassessed with our hearing aid attached. Healthy subjects will wear noise-cancelling headphones and ear plugs to simulate conductive hearing loss, and their hearing threshold will be assessed before and during the flexible hearing aid attachment.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK563267/

Conductive Hearing Loss - StatPearls - NCBI Bookshelf - NIH Hearing loss is often divided into three types: conductive, sensorineural, and mixed.[1] Conductive hearing loss encompasses a range of conditions.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07222202

Evaluation of Flexible Conductive Hearing Aids flexible Band-Aid style hearing device. Patients with conductive/mixed hearing loss will be assessed to observe their hearing threshold ...

3. ichgcp.net ichgcp.net/amp/clinical-trials-registry/NCT07222202

Flexible conductive hearing aid in Conductive Hearing Loss ... Patients with conductive/mixed hearing loss will be assessed to observe their hearing threshold before using the hearing aid and reassessed with our hearing aid ...

4. ctv.veeva.com ctv.veeva.com/study/evaluation-of-flexible-conductive-hearing-aids

Evaluation of Flexible Conductive Hearing Aids Patients with conductive/mixed hearing loss will be assessed to observe their hearing threshold before using the hearing aid and reassessed with ...

5. nature.com nature.com/articles/s44172-025-00369-7

Array of micro-epidermal actuators for noninvasive ... Flexible hearing aids are a noninvasive solution to address pediatric hearing loss. These aids generate vibrations on epidermal layer of skin ...

6. journals.lww.com journals.lww.com/otology-neurotology/fulltext/2022/06000/consensus_statement_on_bone_conduction_devices_and.1.aspx

Consensus Statement on Bone Conduction Devices and ... Since the mid-80 s, several different types of implantable acoustic hearing devices have been developed for patients with conductive and mixed hearing loss.

7. news-medical.net news-medical.net/news/20250313/New-flexible-hearing-aid-offers-non-invasive-solution-for-conductive-hearing-loss.aspx

New flexible hearing aid offers non-invasive solution for ... A new type of hearing aid that not only improves hearing but also offers a safe, non-invasive alternative to implantable devices and corrective surgeries.