Frequency Allocation for Hearing Loss
Recruiting in Palo Alto (17 mi)
Overseen byMario A. Svirsky, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: NYU Langone Health
Disqualifiers: Under 18, Non-English, Cognitive impairments, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
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.
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.
12345How 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.
25678Eligibility 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
I am 18 years old or older.
Pure tone average (.5, 1, and 2kHz) between 30 and 70 dB (decibel) hearing level in the contralateral (hearing aid) ear
Regular usage of a cochlear implant device with at least 18 active electrodes, and compliance with programming/appointments
+6 more
Exclusion Criteria
Non-standard FAT programs
Cognitively impaired
Greater than 70 dB hearing level pure tone average in the contralateral ear
+5 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Experienced UsersExperimental Treatment2 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NYU Langone HealthNew York, NY
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Who Is Running the Clinical Trial?
NYU Langone HealthLead Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)Collaborator
References
Hearing Thresholds at High Frequencies: Age as a Predictor of Values. [2023]Introduction  The audiological evaluation has the main objective of determining the integrity of the auditory system. Pure tone audiometry is a standardized behavioral procedure that aims to investigate auditory thresholds to describe auditory sensitivity. Despite being recognized since the mid-1960s, high frequency audiometry is still little used and explored in clinical practice, and its use is more considered as an audiological monitoring tool or as a research tool. Objective  To analyze the audiological thresholds of high frequency audiometry in normal hearing individuals, and to verify the predictive capacity of age in the auditory thresholds of high frequency audiometry. Methods  This is a retrospective, cross-sectional, and quantitative study that was approved by the Research Ethics Committee under number 5.039.583/21. The procedures were: clinical evaluation, pure tone audiometry, acoustic immittance measurements, and high frequency audiometry. All data collected from the exams were tabulated in an Excel spreadsheet and analyzed using appropriate statistical tests in the Statistical Package Social Sciences software. Results  A total of 980 medical records were analyzed. The right and left ears presented similar tonal hearing thresholds for the frequencies of 12 kHz and 16 kHz. The threshold variance of 29.8% in the 12 kHz frequency can be explained by the variance of age, while, for the frequency of 16 kHz, this percentage is of 46.4%. Conclusion  For 12 kHz hearing thresholds, an increase of 1 year leads to a 0.66 dBHL increase in hearing threshold. For 16 kHz hearing thresholds, an increase of 1 year leads to a 1.02 dBHL increase in hearing threshold.
Dead regions in the cochlea and enhancement of frequency discrimination: Effects of audiogram slope, unilateral versus bilateral loss, and hearing-aid use. [2022]Following a restricted lesion of the cochlea, which produces a "dead region" (DR), animal experiments have revealed an increase in the cortical representation of frequencies just below the edge frequency (f(e)) of the DR. This may result in improved difference limens for frequency (DLFs) just below f(e). In previous studies to assess this, the value of f(e) was not determined precisely. We measured DLFs using human subjects with DRs for whom the values of f(e) had been determined precisely using psychophysical tuning curves. To prevent use of loudness cues, stimuli for the measurement of DLFs had a mean level falling along an equal-loudness contour and levels were roved over a 12-dB range. DLFs were measured for thirteen subjects with a DR in at least one ear. Almost all subjects with bilateral hearing loss exhibited enhanced DLFs near f(e), consistent with cortical reorganisation. This occurred for subjects whose audiograms had both steep and shallow slopes, regardless of hearing aid use, and for two subjects with low-frequency DRs. One subject with a high-frequency DR in one ear and good hearing in the other ear showed an enhanced DLF in her better ear.
The use of psychophysical tuning curves to explore dead regions in the cochlea. [2019]"Dead regions" are regions in the cochlea with no functioning inner hair cells (IHCs) and/or neurons. Amplification (using a hearing aid) over a frequency range corresponding to a dead region may not be beneficial and may even impair speech intelligibility. The objective of this article is to illustrate the use of psychophysical tuning curves (PTCs) as a tool for investigating dead regions and to illustrate the variety of audiogram configurations that can be associated with dead regions. We explore the influence of signal level and signal frequency to test the hypothesis that the frequency at the tip of the tuning curve defines the boundary of the dead region.
[High frequency audiometry]. [2006]The authors have performed a series of high frequency audiograms in order to assess its value in routine otological practice. Initially, they conducted a statistical study on subjects with so-called normal hearing in order to establish standardised normal values. As in the earlier studies, a physiological alteration was observed in the high frequencies which was progressively accentuated with age. Audiometric results should therefore always be considered in relation to the patient's age. A standard graph is proposed for the presentation of the results. The authors subsequently performed high frequency audiometry in patients with internal ear disorders. High frequency audiometry allowed early detection of an alteration in the internal ear, when conventional audiometry was normal. The authors believe that high frequency audiometry should be part of the otological assessment as its allows early detection of internal ear disease.
Plasticity of auditory cortex associated with sensorineural hearing loss in adult C57BL/6J mice. [2007]The representation of frequency was mapped in the primary auditory cortex (AI) of C57BL/6J (C57) mice during young adulthood (1.5-2 months) when hearing is optimal, and at 3, 6, and 12 months of age, a period during which progressive, high frequency, sensorineural hearing loss occurs in this strain. Maps were also obtained from CBA/CaJ mice which retain good hearing as they age. In AI of young adult C57 mice and CBA mice, characteristic frequencies (CFs) of multiple-unit clusters were easily identified with extracellular recordings, and a general tonotopic organization was observed from dorsal (high frequency) to ventral and caudal (low frequency). In individual cases there appeared to be deviations from the above tonotopic organization, despite the fact that inbred mice are genetically invariant. As progressive loss of high frequency sensitivity ensued peripherally, a substantially increased representation of middle frequencies was observed in AI. There was no apparent change in the surface area of the auditory cortex despite the elimination of high frequencies, and virtually the entire auditory cortex became devoted to the middle frequencies (especially 10-13 kHz) for which sensitivity remained high. Similar age-related changes were not observed in normal-hearing CBA mice. These findings indicate that plasticity in the representation of frequency in AI is associated with high frequency hearing loss in C57 mice.
Frequency analysis in normal and hearing-impaired listeners. [2019]Recent studies of frequency analysis in listeners with normal hearing and in those with sensorineural hearing losses are reviewed and compared with related physiological data. These studies suggest that it is now possible to obtain detailed audiological or psychoacoustic data for human listeners that closely parallel physiological data obtained in eighth nerve recordings from animals. Implications of these developments for future research with impaired listeners are discussed.
Reference data for evaluation of occupationally noise-induced hearing loss. [2015]Relevant reference data are required in order to determine the effect from occupational noise exposure on hearing. Pure-tone averages (PTA) of hearing threshold levels simplify the evaluation for audiometric frequencies typically affected by noise. The present study provides reference data of high frequency (HF) PTA over 3, 4 and 6 kHz for a general adult population, aged from 20 to 79 years, not exposed to hazardous occupational noise. The results are presented as statistical distributions of HF PTA values as functions of age, and as prevalence of different degree of HF PTA in the age groups 20-29, 30-39, 40-49, 50-59, 60-69 and 70-79 years.
Frequency organization of the 40-Hz auditory steady-state response in normal hearing and in tinnitus. [2006]We used the 40-Hz auditory steady-state response (SSR) to compare for the first time tonotopic frequency representations in the region of primary auditory cortex (PAC) between subjects with chronic tinnitus and hearing impairment and normal hearing controls. Frequency representations were measured in normal hearing (n=17) and tinnitus (n=28) subjects using eight carrier frequencies between 384 and 6561 Hz, each amplitude modulated (AM) at 40-Hz on trials of 3 min duration under passive attention. In normal hearing subjects, frequency gradients were observed in the medial-lateral, anterior-posterior, and inferior-superior axes, which were consistent with the orientation of Heschl's gyrus and with functional organization revealed by fMRI investigations. The frequency representation in the right hemisphere was approximately 5 mm anterior and approximately 7 mm lateral to that in the left hemisphere, corroborating with MEG measurements hemispheric asymmetries reported by cytoarchitectonic studies of the PAC and by MRI morphometry. In the left hemisphere, frequency gradients were inflected near 2 kHz in normal hearing subjects. These SSR frequency gradients were attenuated in both hemispheres in tinnitus subjects. Dipole power was also elevated in tinnitus, suggesting that more neurons were entrained synchronously by the AM envelope. These findings are consistent with animal experiments reporting altered tonotopy and changes in the response properties of auditory cortical neurons after hearing loss induced by noise exposure. Degraded frequency representations in tinnitus may reflect a loss of intracortical inhibition in deafferented frequency regions of the PAC after hearing injury.