Frequency Allocation for Hearing Loss

Overseen By Megan Eitel

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Under 18, Non-English, Cognitive impairments, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

24 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment for hearing loss?

Research on cochlear 'dead regions' suggests that enhancing frequency discrimination near these areas can improve hearing, which may support the use of customized frequency mapping in the treatment. Additionally, studies on high frequency audiometry indicate its potential for early detection of hearing issues, suggesting that frequency allocation adjustments could be beneficial. ^{1 2 3 4 5}

How does the Experimental Frequency Allocation Table treatment differ from other treatments for hearing loss?

The Experimental Frequency Allocation Table treatment is unique because it customizes frequency mapping based on individual anatomy, potentially enhancing frequency discrimination by targeting specific 'dead regions' in the cochlea. This approach differs from standard treatments by focusing on personalized frequency allocation to improve hearing outcomes. ^{2 5 6 7 8}

What is the purpose of this trial?

This study will examine experienced, bimodal cochlear implant (CI) patients who receive an alternative frequency allocation table (FAT) to determine how it improves sound quality, device satisfaction, and speech perception abilities with respect to the standard default FAT. The goal of this study is to investigate how improving place-pitch mismatch in bimodal CI users affects 1) sound quality, 2) satisfaction, and 3) speech perception.

Research Team

Mario A. Svirsky, PhD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for people with mixed conductive and sensorineural hearing loss, deafness, or general hearing loss who already use a cochlear implant (CI). Specific eligibility criteria are not provided, but typically participants must meet certain health standards and agree to follow the study procedures.

Inclusion Criteria

Pure tone average (.5, 1, and 2kHz) between 30 and 70 dB (decibel) hearing level in the contralateral (hearing aid) ear

I got a cochlear implant over 6 months ago and use a hearing aid in the other ear.

Standard FAT use for all programs prior to study participation

Exclusion Criteria

Non-standard FAT programs

Cognitively impaired

Greater than 70 dB hearing level pure tone average in the contralateral ear

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Experimental FAT Adaptation

Participants are fitted with an experimental frequency allocation table (FAT) and undergo a 1-month adaptation period

4 weeks

Behavioral Visit 2 (1 month post 438 Hz FAT adaptation)

Standard FAT Re-adaptation

Participants undergo a 1-month re-adaptation to the standard frequency allocation table (FAT)

4 weeks

Behavioral Visit 3 (1 month post 188 Hz FAT re-adaptation)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Experimental frequency allocation table (FAT) - 438 Hz
• Standard FAT - 188 Hz

Trial Overview The study tests if a new experimental frequency allocation table (FAT) set at 438 Hz can improve sound quality, satisfaction with the device, and speech perception compared to the standard FAT set at 188 Hz in experienced bimodal CI users.

Participant Groups

Group I: Experienced Users Experimental Treatment 2 Interventions

All subjects will be fit with a modified cochlear implant program ("experimental FAT") that changes which frequencies are presented to the cochlear implant. Subjects will complete a 1 month adaptation to the experimental FAT (438 Hz) and then a one month re-adaptation to the standard FAT (188 Hz). Speech perception tests and questionnaires will be collected before and after each FAT adaptation.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Findings from Research

A study analyzing 980 medical records found that high frequency audiometry (12 kHz and 16 kHz) can effectively assess auditory thresholds in individuals with normal hearing, showing similar results for both ears.

Age significantly impacts high frequency hearing thresholds, with each additional year correlating to a 0.66 dBHL increase at 12 kHz and a 1.02 dBHL increase at 16 kHz, indicating that older individuals may experience greater hearing threshold shifts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hearing Thresholds at High Frequencies: Age as a Predictor of Values. Chiriboga, LF., Sideri, KP., Chamouton, CS., et al.[2023]

In a study involving thirteen human subjects with 'dead regions' in their cochlea, enhanced frequency discrimination abilities (difference limens for frequency, or DLFs) were observed just below the edge frequency of the dead region, suggesting cortical reorganization in response to hearing loss.

This enhancement in DLFs occurred regardless of the steepness of the subjects' audiograms or whether they used hearing aids, indicating that the brain can adapt to changes in auditory input even in cases of significant hearing impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dead regions in the cochlea and enhancement of frequency discrimination: Effects of audiogram slope, unilateral versus bilateral loss, and hearing-aid use. Kluk, K., Moore, BC.[2022]

Psychophysical tuning curves (PTCs) effectively identify and define 'dead regions' in the cochlea of individuals with sensorineural hearing loss, indicating areas without functioning inner hair cells or neurons.

The frequency at the tip of the PTC can help approximate the boundary of these dead regions, revealing that they can exist even at frequencies where hearing thresholds are nearly normal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of psychophysical tuning curves to explore dead regions in the cochlea. Moore, BC., Alcántara, JI.[2019]

High frequency audiometry can reveal early signs of internal ear disorders even when conventional audiometry shows normal results, making it a valuable tool in otological assessments.

The study established standardized normal values for high frequency hearing based on age, highlighting the importance of considering a patient's age when interpreting audiometric results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[High frequency audiometry]. Klap, P., Fiaux, JM., Leca, F., et al.[2006]

In C57BL/6J mice, which experience progressive high-frequency hearing loss as they age, the primary auditory cortex shows increased representation of middle frequencies, indicating a plastic response to the loss of high-frequency sensitivity.

Unlike C57 mice, CBA/CaJ mice, which maintain good hearing, do not exhibit these age-related changes in frequency representation, suggesting that the observed plasticity in the auditory cortex is specifically linked to hearing loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plasticity of auditory cortex associated with sensorineural hearing loss in adult C57BL/6J mice. Willott, JF., Aitkin, LM., McFadden, SL.[2007]

Recent studies indicate that detailed audiological and psychoacoustic data can be obtained from listeners with normal hearing and those with sensorineural hearing loss, closely aligning with physiological data from animal studies.

These advancements suggest promising implications for future research aimed at understanding and improving hearing in impaired listeners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequency analysis in normal and hearing-impaired listeners. Jesteadt, W.[2019]

This study provides essential reference data for high frequency pure-tone averages (PTA) of hearing thresholds in adults aged 20 to 79 years who are not exposed to hazardous occupational noise, which is crucial for evaluating the impact of noise on hearing.

The results include statistical distributions of HF PTA values by age group, helping to establish a baseline for normal hearing levels and the prevalence of different degrees of hearing loss across various age ranges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reference data for evaluation of occupationally noise-induced hearing loss. Johansson, M., Arlinger, S.[2015]

In a study comparing 28 tinnitus subjects to 17 normal hearing controls, it was found that frequency representations in the primary auditory cortex were significantly altered in tinnitus patients, indicating degraded auditory processing.

The results suggest that tinnitus may be linked to a loss of intracortical inhibition in the auditory cortex, as evidenced by attenuated frequency gradients and increased dipole power in tinnitus subjects, which aligns with previous animal studies on hearing loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequency organization of the 40-Hz auditory steady-state response in normal hearing and in tinnitus. Wienbruch, C., Paul, I., Weisz, N., et al.[2006]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Hearing Thresholds at High Frequencies: Age as a Predictor of Values. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Dead regions in the cochlea and enhancement of frequency discrimination: Effects of audiogram slope, unilateral versus bilateral loss, and hearing-aid use. [2022]

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

The use of psychophysical tuning curves to explore dead regions in the cochlea. [2019]

4. France pubmed.ncbi.nlm.nih.gov

[High frequency audiometry]. [2006]

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

Plasticity of auditory cortex associated with sensorineural hearing loss in adult C57BL/6J mice. [2007]

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

Frequency analysis in normal and hearing-impaired listeners. [2019]

7. India pubmed.ncbi.nlm.nih.gov

Reference data for evaluation of occupationally noise-induced hearing loss. [2015]

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

Frequency organization of the 40-Hz auditory steady-state response in normal hearing and in tinnitus. [2006]