Hearing Aid Technology for Hearing Loss

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Advanced Bionics

Disqualifiers: Significant medical condition, others

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

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of different hearing aid technologies for individuals with hearing loss. Researchers aim to determine whether a microphone placed on the outer ear (pinna) or a computer algorithm that mimics the ear's shape (pinna-simulated microphone algorithm) provides better sound quality. Participants will use both types and provide feedback on their performance. This trial suits individuals who can operate hearing aid controls and follow study instructions. Participants must speak English fluently. As an unphased trial, this study offers a unique opportunity to contribute to advancements in hearing aid technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these hearing aid technologies are safe?

Research has shown that hearing aid technologies, like those used in this trial, are generally safe. Studies indicate that the microphone located on the outer ear helps people hear their surroundings better. Most users report improved sound quality without major issues.

Evidence suggests that the microphone algorithm, which mimics the ear's shape, processes sounds effectively. This technology is safe because it relies on methods already in use. No reports of unexpected safety problems have emerged with these technologies, allowing participants to feel confident about their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for hearing loss because they explore innovative approaches to capturing and processing sound. Unlike traditional hearing aids that use microphones placed behind the ear, one treatment places the microphone directly on the pinna (the outer part of the ear), which may provide a more natural sound experience by capturing audio more like a natural ear. The other treatment uses a pinna-simulated microphone algorithm, which digitally mimics how the pinna processes sound, potentially enhancing sound clarity and spatial awareness. These novel approaches could lead to hearing aids that not only improve sound quality but also offer a more natural listening experience, addressing some of the limitations of current hearing aid technology.

What evidence suggests that this trial's treatments could be effective for hearing loss?

This trial will compare two hearing aid technologies: a pinna-located microphone and a pinna-simulated microphone algorithm. Research has shown that microphones placed on the outer ear can improve hearing. One study found that this setup helps users better identify sound origins. Another study discovered that maintaining natural ear cues benefits people with mild to moderate hearing loss. For the microphone technology that mimics the ear's shape, studies have shown promising results, helping users more accurately determine sound direction. Both technologies in this trial aim to improve how users hear and understand speech in noisy environments. These findings suggest potential benefits for people considering these hearing aid options. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults and children aged 8-17 with hearing loss or ear infections who can legally consent and follow study instructions. Children must be accompanied by a guardian. Participants should be able to operate the device controls and speak English.

Inclusion Criteria

I am at least 8 years old.

English language proficiency as determined by the investigator

I can use the study device and follow all instructions.

Exclusion Criteria

Have any significant medical condition that, in the opinion of any of the investigators, is likely to interfere with study procedures or likely to confound evaluation of study endpoints

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment

Initial visit for baseline performance assessment using AzBio sentences and localization tasks

1 day

1 visit (in-person)

Chronic Use and Assessment

Participants use the devices for two-week intervals with assessments of usability and preference

8 weeks

4 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after the main assessments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pinna-located microphone
• Pinna-simulated microphone algorithm

Trial Overview The study tests the effectiveness of FDA-approved Sonova products using pinna-located microphones versus simulated microphone algorithms in improving hearing performance.

How Is the Trial Designed?

Group I: Microphone Location versus Microphone Algorithm Comparison Experimental Treatment 2 Interventions

Comparing performance and subjective feedback for pinna-located microphone versus a pinna-simulated microphone algorithm.

Who Is Running the Clinical Trial?

Advanced Bionics

Lead Sponsor

Trials

17

Recruited

500+

Published Research Related to This Trial

A new ear modeling method using acoustic filter theory was developed for a digital hearing aid chip, allowing for real-time feedback and improved programmability.

The fabricated digital hearing aid chip, built using 0.18 microm CMOS technology, is compact (3.1 mm x 1.2 mm) and energy-efficient, consuming less than 120 microamperes, making it suitable for practical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The reference ear modeling method for internally feedback controlled digital hearing aid chip. Kim, S., Lee, SJ., Cho, N., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7757747/

Pinna-Imitating Microphone Directionality Improves Sound ... Our results demonstrate that PI mode can lead to improved spatial hearing performance in bilateral cochlear implant users.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4070616/

Laboratory and Field Study of the Potential Benefits ... The results suggest that preserving pinna cues can offer benefit in some conditions for individual hearing-aid users with mild to moderate hearing loss and is ...

3. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2024.1475122/full

Improving speech intelligibility in noise and spatial ... This study demonstrated that TIE provided better speech intelligibility, localization accuracy, and user satisfaction compared to RITE.

4. ejo.springeropen.com ejo.springeropen.com/articles/10.1186/s43163-025-00858-8

Impact of microphone and receiver-in-the ear hearing aid ... The study concludes that the position of the microphone significantly influences auditory performance; the transducer in the ear provided better ...

5. pubs.asha.org pubs.asha.org/doi/10.1044/2022_AJA-22-00061

Perceived Sound Quality of Hearing Aids With Varying ... Perceived sound quality was variously compared between either no aiding or aiding with three models of hearing aid that varied the microphone position around ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK616586/

Outcomes for Hearing Health Interventions - NCBI - NIH The most common treatment for sensorineural hearing loss involves amplifying the incoming signal to improve hearing function. This is accomplished most often ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4111438/

Middle Ear Implantable Hearing Devices: An Overview - PMC Phase III trial results noted that the device was safe, and 94% of patients stated an improvement in overall sound quality over conventional hearing aids ( ...

8. pubs.asha.org pubs.asha.org/doi/10.1044/2022_AJA-22-00006

Sound Localization of Listeners With Normal Hearing ... They found that microphone location was the only variation that significantly affected vertical localization accuracy, in keeping with previous studies and ...

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P000025S104B.pdf

FDA - Summary of Safety and Effectiveness Data (SSED) o Reduced or loss of pinna sensitivity on the surgical side ... have bilateral severe-to-profound hearing loss, and no other unexpected safety.