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Investigation of Anatomical Correlates of Speech Discrimination

Investigation of Anatomical Correlates of Speech Discrimination

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01781039
Enrollment
186
Registered
2013-01-31
Start date
2013-01-01
Completion date
2019-12-12
Last updated
2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sensorineural Hearing Loss

Keywords

"hair cell", "hearing aid", "hearing loss", "auditory nerve", synaptopathy, "Outer hair cell", "Otoacoustic emission"

Brief summary

Understanding speech is essential for good communication. Individuals with hearing loss and poor speech discrimination often have little success with hearing aids because amplifying sound improves audibility, but not clarity of the speech signal. The purpose of this study is to determine the relative importance of the sensory cells of the inner ear and auditory neurons on speech discrimination performance in quiet and in noise. This information may be used as a predictor of hearing aid benefit. The investigators expect to find decreased speech understanding ability resulting from both loss of sensory cells and the loss of auditory neurons.

Detailed description

Patients receiving routine audiologic evaluations who meet study criteria will be asked to participate in the study. Study participants will receive an ABR and DPOAE evaluation and speech-in-noise testing. Participants who are hearing aid candidates will be fit with loaner hearing aids with noise reduction technology for 2 weeks. Wave 1 amplitudes from the ABR, DPOAE levels, speech discrimination scores, unaided and aided speech0in-noise performance age, and pure tone thresholds will be recorded, as well as any audiologic diagnosis that may confound the results.

Interventions

Subjects with hfPTAs ranging from 0-55 dB HL will be recruitedwith 100 persons self-reporting difficulty HIN (\> 50% of the time), and 100 persons reporting little difficulty HIN (\< 50% of the time) will be randomly assigned to one of five groups (n = 200) based on enabled HA features using an online random assignment tool. Unaided HIQ and HIN assessments will be conducted in the sound field, and baseline DPOAE and CAP assessments will be measured. Subjects will be fit with binaural premium level receiver-in-the canal HAs (Phonak B90 or equivalent model at the start of the study) with 56 dB SPL gain receivers, using closed domes, and programmed to NAL-NL2 target gain, and randomly assigned to the groups.

Sponsors

Steward St. Elizabeth's Medical Center of Boston, Inc.
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

* Normal hearing to moderate sensorineural hearing loss * Sufficient English proficiency to complete speech discrimination testing in English

Exclusion criteria

* Hearing loss less than a 45 dB HL pure tone average (average hearing thresholds at 500, 1000 and 2000 Hz) * Conductive hearing loss * Neurodegenerative disease

Design outcomes

Primary

MeasureTime frameDescription
Regression analysisJune 2024Regression analysis will be used to look for a correlation between measures of sensory cell and auditory neuron survival and speech recognition performance.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMark Parker, PhD

Steward St. Elizabeth's Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026