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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for setting frequencies in cochlear implants, known as the experimental frequency allocation table (FAT) - 438 Hz, to determine if it improves sound quality, device satisfaction, and speech understanding. Participants will use this new frequency setting for a month before returning to the usual setting to compare results. It may suit individuals who have used a cochlear implant with a hearing aid for at least six months and have moderate to severe hearing levels in the ear with the hearing aid. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could enhance cochlear implant technology.

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 prior data suggests that this frequency allocation table is safe for cochlear implant users?

Research has shown that adjusting frequency settings in cochlear implants can improve hearing. One study explored how these adjustments can help new users hear better. Another study introduced a tool that allows users to select the frequency settings that best enhance their speech understanding.

The current treatment, known as the Experimental Frequency Allocation Table (FAT), aims to enhance sound quality by better aligning frequency settings with each person's ear. This approach may reduce the mismatch between sound frequencies and their intended location in the ear, potentially improving hearing satisfaction.

While specific reports of side effects for this new frequency table are absent, it builds on existing cochlear implant technology, suggesting it could be well-tolerated. Since this trial phase is "Not Applicable," it likely focuses on understanding the effects rather than testing basic safety. This implies the treatment is expected to be safe based on earlier research and the nature of the changes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Frequency Allocation for Hearing Loss trial because it explores a new way of using cochlear implants by adjusting the frequencies that are delivered to the ear. Unlike standard cochlear implant programs that use a fixed frequency allocation, this trial tests an experimental frequency allocation table (FAT) set at 438 Hz. The goal is to determine if this new frequency setting can improve speech perception. By focusing on how different frequencies affect hearing, researchers hope to enhance the effectiveness of cochlear implants and improve the overall listening experience for users.

What evidence suggests that this experimental frequency allocation table is effective for improving sound quality, satisfaction, and speech perception in hearing loss?

This trial will evaluate different frequency allocation settings for cochlear implants. Studies have shown that adjusting sound frequencies in cochlear implants can improve hearing. Research suggests that using a specific frequency setting, such as the experimental 438 Hz frequency allocation table (FAT), which aligns with the natural way ears process sound, can clarify sounds and enhance speech understanding. This approach reduces the mismatch between sounds and their perception in the ear, potentially increasing satisfaction with the device. Previous studies have demonstrated that customizing these frequency settings for each person can significantly enhance speech hearing. These findings suggest that a personalized frequency setup based on individual ear structure could improve the hearing experience for cochlear implant users. Participants in this trial will experience both the experimental FAT and the standard FAT to assess the impact on speech perception and satisfaction. ^{1 3 5 6 7}

Who Is on the Research Team?

Mario A. Svirsky, PhD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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

Standard FAT use for all programs prior to study participation

English speaking

Exclusion Criteria

Non-standard FAT programs

Cognitively impaired

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06734039

Impact of Anatomy-Based Cochlear Implant Programming ... The purpose of this study is to evaluate the impact of different audio processor frequency settings on performance outcomes in new cochlear implant users.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10133468/

Imaging-based frequency mapping for cochlear implants We introduce an imaging-based fitting intervention, which aimed to reduce frequency-to-place mismatch by aligning frequency mapping with the tonotopic position ...

3. nature.com nature.com/articles/s41598-024-83047-6

Learning to hear again with alternating cochlear frequency ... Cochlear implants restore hearing by arbitrarily mapping frequency-amplitude information. This study shows that recipients, after a long ...

4. withpower.com withpower.com/trial/phase-hearing-loss-9-2024-651da

Frequency Allocation for Hearing Loss The Experimental Frequency Allocation Table treatment is unique because it customizes frequency mapping based on individual anatomy, potentially enhancing ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34967457/

Anatomy-Based Frequency Allocation in Cochlear ... This study aimed to compare the predicted anatomy-based frequency allocation of cochlear implant electrodes with the default standard frequencies.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2962926/

A New Software Tool to Optimize Frequency Table ... A software tool was designed that enables CI users to self-select a “most intelligible” frequency table.

7. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2023.1119933/full

Imaging-based frequency mapping for cochlear implants We introduce an imaging-based fitting intervention, which aimed to reduce frequency-to-place mismatch by aligning frequency mapping with the tonotopic position ...