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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess the effectiveness and optimization of various FDA approved products.

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 data supports the effectiveness of the treatment Pinna-located microphone, Pinna-simulated microphone algorithm for hearing loss?

Research suggests that preserving pinna cues (the natural way our ears help us locate sounds) in hearing aids can help some users with mild to moderate hearing loss better identify where sounds are coming from, especially in the front-back direction. This means the treatment might improve sound localization for some people without negatively affecting others. ^{1 2 3 4 5}

Is the pinna-located microphone hearing aid technology safe for humans?

The research suggests that preserving pinna cues in hearing aids is unlikely to harm users with mild to moderate hearing loss, and no significant safety concerns were reported in the studies reviewed. ^{1 2 4 6 7}

How does the hearing aid technology treatment for hearing loss differ from other treatments?

This hearing aid technology is unique because it preserves the natural cues provided by the pinna (the outer part of the ear), which can improve sound localization and speech understanding in some situations. Unlike traditional hearing aids, this approach aims to maintain the high-frequency spectral cues that help users better perceive where sounds are coming from. ^{1 2 8 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Laboratory and field study of the potential benefits of pinna cue-preserving hearing aids. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

The effect of probe tube reference placement on sound pressure level variability. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Clinical ear canal probe tube measurements. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Attenuating the ear canal feedback pressure of a laser-driven hearing aid. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Fitting Assistive Technology for People with Hearing Loss: The Importance of Remote Microphone Systems' Electroacoustic Verification. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A New Trans-Tympanic Microphone Approach for Fully Implantable Hearing Devices. [2018]

7. England pubmed.ncbi.nlm.nih.gov

A comparison of CIC and BTE hearing aids for three-dimensional localization of speech. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Speech Intelligibility in Noise With a Pinna Effect Imitating Cochlear Implant Processor. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

A digital master hearing aid. [2007]

10. United States pubmed.ncbi.nlm.nih.gov

The reference ear modeling method for internally feedback controlled digital hearing aid chip. [2020]