Investigation of Anatomical Correlates of Speech Discrimination

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.

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Key information

Conditions

Sensorineural Hearing Loss Cranial Nerve Diseases Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Retrocochlear Diseases Sensation Disorders Signs and Symptoms Vestibulocochlear Nerve Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Steward St. Elizabeth's Medical Center

Brighton, Massachusetts, 02135, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hearing Aid fitting

Device

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.

Primary outcomes

Regression analysis

Time frame: June 2024

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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2019
Study completion: 2019
First posted: Jan 31, 2013
Registry last updated: Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed