Hearing Aid Enhancements for Hearing Loss

Overseen By Christine Mason

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston University Charles River Campus

Disqualifiers: Non-native English speakers, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

220 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve how hearing-aid users understand speech and perceive sound in noisy environments with multiple speakers. Researchers are testing various hearing-aid settings, such as making high-pitched sounds more audible and enhancing speech clarity. Individuals with normal hearing or sensorineural hearing loss (a common type of permanent hearing loss) may be suitable if they struggle to follow conversations in busy settings. Participants will encounter different sound scenarios to test these enhancements. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance hearing-aid technology for everyone.

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 enhancements are safe for users?

Research shows that hearing aids are generally easy to use. A review found that various types of hearing aids assist those with hearing loss and are safe for most users, with serious side effects being rare.

Hearing aids are commonly used to enhance hearing, especially in noisy environments, such as when many people are talking simultaneously. This study aims to improve their effectiveness in these challenging listening situations.

In summary, hearing aids are a safe choice for most people, and this study seeks to enhance their effectiveness for everyday use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the new hearing aid enhancements because they simulate different sound conditions to improve how users perceive and process sound. Unlike traditional hearing aids that primarily amplify sound, these experimental conditions aim to optimize sound clarity and comprehension in various environments. By tailoring sound delivery more precisely, this approach could significantly enhance the listening experience for individuals with hearing loss, making everyday interactions more seamless and natural.

What evidence suggests that these hearing aid enhancements are effective for improving spatial perception and speech intelligibility in hearing loss?

Research shows that hearing aids can greatly enhance speech comprehension. Studies have found that modern hearing aids improve hearing, especially in challenging listening environments. One study found that hearing aids enhanced listening skills and quality of life for older adults with hearing loss. These devices help users hear high-pitched sounds and clarify speech, making conversations easier to follow in noisy places. Participants in this trial will encounter various experimental conditions simulating different hearing-aid enhancements to assess their effectiveness. ^{2 6 7 8 9}

Who Is on the Research Team?

Virginia A Best, PhD

Principal Investigator

Boston University

Are You a Good Fit for This Trial?

This trial is for adults with hearing loss. Young adults (18-35) must have normal hearing levels, while older participants (up to 80) should have sensorineural hearing loss. All must understand English, provide consent, and have normal or corrected vision.

Inclusion Criteria

I am 18-35, with normal hearing and vision (with or without correction), and can understand the study.

I am between 18-80 years old with sensorineural hearing loss and can see normally or with correction.

Exclusion Criteria

Non-native speakers of English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline measurements of interaural time difference discrimination, speech intelligibility, externalization rating, and speech reception threshold are conducted

Up to 4 hours

Intervention

Participants are exposed to various hearing-aid conditions to assess improvements in spatial perception and speech intelligibility

Up to 4 hours

Follow-up

Participants are monitored for any changes in spatial perception and speech intelligibility post-intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hearing Aid Condition

Trial Overview The study tests if spatial perception and speech clarity in noisy environments can be improved for hearing aid users through increased high-frequency sounds, speech envelope enhancement, or better sound image externalization.

How Is the Trial Designed?

Group I: Experimental condition Experimental Treatment 1 Intervention

Participants will be presented with sound stimuli under a number of experimental conditions that simulate different hearing-aid conditions.

Hearing Aid Condition is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Hearing Aid for:

• Hearing Loss
• Sensorineural Hearing Loss
• Conductive Hearing Loss

Approved in United States as Hearing Aid for:

• Hearing Loss
• Sensorineural Hearing Loss
• Conductive Hearing Loss

Approved in Canada as Hearing Aid for:

• Hearing Loss
• Sensorineural Hearing Loss
• Conductive Hearing Loss

Approved in Japan as Hearing Aid for:

• Hearing Loss
• Sensorineural Hearing Loss
• Conductive Hearing Loss

Approved in China as Hearing Aid for:

• Hearing Loss
• Sensorineural Hearing Loss
• Conductive Hearing Loss

Approved in Switzerland as Hearing Aid for:

• Hearing Loss
• Sensorineural Hearing Loss
• Conductive Hearing Loss

Who Is Running the Clinical Trial?

Boston University Charles River Campus

Lead Sponsor

Trials

125

Recruited

14,100+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Published Research Related to This Trial

Implantable hearing aids offer significant advantages over conventional hearing aids, including better sound fidelity, elimination of the occlusion effect, and reduced risk of acoustic feedback, as they transmit mechanical vibrations directly to the auditory system instead of relying on sound.

Different types of implantable hearing aids are designed for specific types of hearing loss: impedance transformation implants (ITI) for conductive hearing loss and cochlea amplifier implants (CAI) for sensorineural hearing loss, addressing the unique needs of each patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Active electronic cochlear implants for middle and inner ear hearing loss--a new era in ear surgery. I: Basic principles and recommendations on nomenclature]. Zenner, HP., Leysieffer, H.[2019]

Cochlear implants (CIs) provide significantly better hearing improvement for patients with severe to profound hearing loss compared to conventional hearing aids, making them a more effective treatment option.

The MED-EL multichannel CI system has shown high reliability, with no technical failures reported over a 5-year observation period, highlighting the advancements in implant technology and design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device profile of the MED-EL cochlear implant system for hearing loss: overview of its safety and efficacy. Baumann, U., Stöver, T., Weißgerber, T.[2022]

The Otologics fully implantable hearing system demonstrated safety and effectiveness in providing sound amplification for patients with moderate to severe sensorineural hearing loss, with performance comparable to traditional hearing aids after one year of use.

While there were some adverse effects, including device extrusions and communication loss, most issues were resolved by the time of activation, indicating that the device can be a viable option for patients seeking an implantable solution.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Otologics fully implantable hearing system: Phase I trial 1-year results. Jenkins, HA., Atkins, JS., Horlbeck, D., et al.[2015]

Recent advancements in the design and functionality of wearable hearing aids have significantly increased their effectiveness, allowing more people with hearing impairments to benefit from them.

Current guidelines for recommending hearing aids are outdated; now, individuals with any level of permanent hearing loss should be considered for aural rehabilitation and the use of hearing aids, regardless of their previous prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The successful hearing aid user. Sanders, JW.[2000]

Hearing aids are essential for patients with noncorrectable hearing loss, aiming to amplify speech for better understanding, enhance environmental sound awareness, and support language development in children with early hearing loss.

The article reviews the current technology of hearing aids, highlighting their benefits and limitations, while also addressing important medical considerations for fitting these devices in patients' ears.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hearing aid evaluation and fitting. Popelka, GR., Gates, GA.[2012]

In a study of 1653 adults fitted with hearing aids, higher satisfaction with hearing aid attributes such as fit, clarity, and comfort significantly correlated with better outcomes, as measured by the International Outcome Inventory for Hearing Aids (IOI-HA).

The research identified that satisfaction in various listening situations, including conversations and group settings, plays a crucial role in improving overall hearing aid effectiveness, suggesting that audiologists should focus on these areas during rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with hearing aid fitting outcomes on the IOI-HA. Hickson, L., Clutterbuck, S., Khan, A.[2022]

The Otologics fully implantable hearing device effectively improves hearing in adults with mixed conductive and sensorineural hearing loss, showing an average functional gain of 26.17 dB across various frequencies after implantation.

Significant improvements in word recognition scores were observed when comparing unaided hearing to hearing with the implant, indicating that the device enhances the user's ability to understand speech.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of the safety and performance of the Otologics fully implantable hearing device: transducing sounds via the round window membrane to the inner ear. Lefebvre, PP., Martin, C., Dubreuil, C., et al.[2009]

Hearing aids have been shown to provide significant functional and communicative benefits for adults with hearing impairments, improving their quality of life and psychosocial well-being.

The review of various studies and evaluations aims to encourage individuals with hearing loss to try hearing aids, highlighting their effectiveness as a rehabilitative service provided by audiologists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment efficacy: hearing aids in the management of hearing loss in adults. Weinstein, BE.[2018]

A new electromagnetic, semi-implantable hearing device showed significant improvements in sound gain and output for individuals with sensorineural hearing loss, outperforming conventional hearing aids in pure-tone testing and providing better sound quality without acoustic feedback.

Patient feedback was very positive, highlighting that the device functions well in noisy environments and delivers a more natural sound compared to traditional hearing aids, leading to further investigation in patients with mixed hearing losses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electromagnetic semi-implantable hearing device: phase I. Clinical trials. McGee, TM., Kartush, JM., Heide, JC., et al.[2019]

The study found that to effectively amplify high frequencies (specifically 10 kHz) for individuals with mild to moderate cochlear hearing loss, a gain of about 36 dB is necessary, which could restore partial audibility for many patients.

Audiometric measurements revealed that while individuals had relatively good hearing thresholds below 4 kHz, their thresholds at high frequencies (10 and 12.5 kHz) were significantly poorer, indicating a need for improved hearing aid fitting procedures that include high-frequency amplification.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spectro-temporal characteristics of speech at high frequencies, and the potential for restoration of audibility to people with mild-to-moderate hearing loss. Moore, BC., Stone, MA., Füllgrabe, C., et al.[2021]

For patients with moderate to severe hearing loss who cannot benefit from conventional hearing aids due to anatomical issues or chronic infections, implantable devices like middle ear and bone conduction implants can provide significant improvements in speech understanding and quality of life.

These implantable devices work by directly stimulating the skull, middle ear structures, or cochlea, offering a viable alternative for those who have not had success with traditional hearing aids or surgical options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Bone Conduction and Active Middle Ear Implants]. Volkenstein, S., Thomas, JP., Dazert, S.[2017]

A study analyzing adverse event reports for cochlear implants found that most incidents involved patient injury (16,736 cases) and device malfunction (10,760 cases), highlighting areas for potential safety improvements.

Using machine learning algorithms, researchers achieved high prediction accuracy (up to 88.6%) in identifying the cochlear implant manufacturer and type of adverse event based on the descriptions, suggesting that data analysis can enhance understanding of device performance and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Machine learning for pattern detection in cochlear implant FDA adverse event reports. Crowson, MG., Hamour, A., Lin, V., et al.[2021]

The review of adverse events associated with bone-conduction hearing implants (BCHIs) and active middle-ear implants (aMEIs) found that the reporting quality of these events is often low, indicating a need for improved documentation in future studies.

Despite the variability in adverse event types and frequencies between BCHIs and aMEIs, the analysis concluded that both types of implants are generally safe treatment options for hearing loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events associated with bone-conduction and middle-ear implants: a systematic review. Schwab, B., Wimmer, W., Severens, JL., et al.[2021]

Citations

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2. mdpi.com mdpi.com/2227-9032/13/15/1795

Music Therapy Outcomes in Older Adults Using Cochlear ... Modern auditory prostheses significantly enhance speech perception and intelligibility. However, users of both cochlear implants and hearing aids (HAs) require ...

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Sensory Aids, Devices, and Prostheses - Hearing Loss - NCBI Many individuals find that the positive benefits of the prosthesis do not outweigh the negative consequences (such as ear discomfort, feedback squeal, high cost ...

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Rehabilitation of human hearing with a totally implantable ... The primary objective of this study was to assess the safety of the device in adults who suffer from bilateral severe-to-profound sensorineural hearing loss.

5. bmcgeriatr.biomedcentral.com bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-021-02033-z

Evaluation of the efficacy of hearing aids in older adults This study aims to show the potential positive effect of HAs on auditory skills and on quality of life of older adults with hearing loss. In ...

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SUMMARY OF SAFETY AND EFFECTIVENESS DATA The SOUNDTEC® Direct System is contraindicated for subjects who have conductive hearing loss, retrocochlear or central auditory disorder, active ...

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Auditory Osseointegrated Implants This document outlines VA's community care coverage determination for Auditory Osseointegrated Implants. At this time, this treatment is ...

8. mayoclinic.org mayoclinic.org/tests-procedures/cochlear-implants/about/pac-20385021

Cochlear implants A cochlear implant is an electronic device that improves hearing. It can be a choice for people who have severe hearing loss from inner-ear damage and can't ...

9. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK578178/

Implantable Hearing Devices - StatPearls - NCBI Bookshelf Implantable hearing devices offer exciting developments in treating hearing loss in patients who previously had poor treatment options.