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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to investigate several approaches for improving spatial perception and speech intelligibility in multitalker listening situations for hearing-aid users. The hypotheses are that spatial perception and speech intelligibility will be improved by (1) increased high-frequency audibility, (2) speech envelope enhancement, and/or (3) appropriate sound image externalization.

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 Hearing Aid Condition, Hearing Aid, Auditory Prosthetic Device, Hearing Instrument for hearing loss?

Research shows that hearing aids significantly improve the ability to understand speech and hear environmental sounds, enhancing the quality of life for those with hearing loss. Studies highlight that users report satisfaction with hearing aid performance in various listening situations, and new technologies continue to improve these outcomes. ^{1 2 3 4 5}

Is the use of hearing aids and related devices generally safe for humans?

Research shows that hearing devices like cochlear implants and fully implantable hearing systems have been studied for safety. Some adverse events have been reported, such as patient injury and device malfunction, but these studies help improve safety and design over time. ^{6 7 8 9 10}

How does the Hearing Aid Condition treatment differ from other treatments for hearing loss?

The Hearing Aid Condition treatment, which involves conventional hearing aids, differs from other treatments like cochlear implants and electromagnetic hearing devices by primarily amplifying sound within the ear canal. Unlike implantable devices that bypass the ear canal and directly stimulate the auditory system, conventional hearing aids can face issues like acoustic feedback and require a tight ear mold, but they are non-invasive and widely accessible. ^{5 8 11 12 13}

Research Team

Virginia A Best, PhD

Principal Investigator

Boston University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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 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]

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]

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]

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]

References

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

The successful hearing aid user. [2000]

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

Hearing aid evaluation and fitting. [2012]

3. England pubmed.ncbi.nlm.nih.gov

Factors associated with hearing aid fitting outcomes on the IOI-HA. [2022]

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

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

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

Electromagnetic semi-implantable hearing device: phase I. Clinical trials. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

Adverse events associated with bone-conduction and middle-ear implants: a systematic review. [2021]

7. Switzerland 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. [2009]

8. England pubmed.ncbi.nlm.nih.gov

Device profile of the MED-EL cochlear implant system for hearing loss: overview of its safety and efficacy. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Machine learning for pattern detection in cochlear implant FDA adverse event reports. [2021]

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

Otologics fully implantable hearing system: Phase I trial 1-year results. [2015]

11. United States 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. [2021]

12. Germany 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]. [2019]

13. Germany pubmed.ncbi.nlm.nih.gov

[Bone Conduction and Active Middle Ear Implants]. [2017]