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Investigation of Anatomical Correlates of Speech Discrimination

S

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

Status

Enrolling

Conditions

Sensorineural Hearing Loss

Treatments

Device: Hearing Aid fitting

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

1,652 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

1,652 participants in 7 patient groups

low HIN difficulty- anesthetized
Description:
Subjects with normal OHC function and who will be undergoing an previously scheduled anesthetized procedure will be assigned into 2 groups based on their self-perceived HIN difficulty (high and low difficulty), and then undergo a test battery consisting of auditory threshold tests, objective HIN assays, OHC measurements, cognitive processing, and central auditory processing evaluations. Immediately after anesthetization, electrocochleography (ECochG) will be used to measure CAP amplitudes, which will be correlated with measurements obtained from unanesthetized subjects as described below. This aim will determine the optimal CAP recording method with the strongest correlation with HIN performance in humans
high HIN difficulty- anesthetized
Description:
Subjects with normal OHC function and who will be undergoing an previously scheduled anesthetized procedure will be assigned into 2 groups based on their self-perceived HIN difficulty (high and low difficulty), and then undergo a test battery consisting of auditory threshold tests, objective HIN assays, OHC measurements, cognitive processing, and central auditory processing evaluations. Immediately after anesthetization, electrocochleography (ECochG) will be used to measure CAP amplitudes, which will be correlated with measurements obtained from unanesthetized subjects as described below. This aim will determine the optimal CAP recording method with the strongest correlation with HIN performance in humans
Hearing Aid fitting: MAD
Description:
Microphone adaptive directionality (MAD) feature will be activated, the WDC set to linear, and the DNR minimized
Treatment:
Device: Hearing Aid fitting
Hearing Aid fitting: WDC
Description:
Wide dynamic compression (WDC) feature will be set to target levels, the MAD feature set to omnidirectional, and the DNR minimized.
Treatment:
Device: Hearing Aid fitting
Hearing Aid fitting: DNR
Description:
Digital noise reduction (DNR) set to maximum, MAD set to omnidirectional, and WDC set to linear
Treatment:
Device: Hearing Aid fitting
Hearing Aid fitting: Positive control
Description:
All hearing aid features enables
Treatment:
Device: Hearing Aid fitting
Hearing Aid fitting: Negative control
Description:
All hearing aid features disabled
Treatment:
Device: Hearing Aid fitting

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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