Understanding Aided Speech Perception in Noise

NCT06377215 | Recruiting FDA Device

• 2 other identifiers: Pro00041729R01DC020514
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

The overarching hypothesis to be evaluated using this protocol is that age-related hearing loss (ARHL) leads to shifts in the functional spatial boundaries between segregated and integrated auditory streams, and that hearing aid intervention that relies on directional processing schemes is most effective for those that have the poorest spatial sensitivity. One key component of the research design is to measure both behavioral and neurophysiological indices of an individual's spatial segregation boundary. The second key component is to measure the cost or benefit associated with hearing aid intervention in older hearing-impaired listeners. The final component is to relate cost and benefit of hearing aid intervention to spatial sensitivity measures that might predict the efficacy of clinical intervention.

Conditions

Hearing Impairment, Sensorineural; Spatial Perception; Aging; Hearing Aids

Keywords

electrophysiology; binaural hearing; auditory scene analysis; auditory streaming; speech perception; localization; psychoacoustics

Outcome Measures

Primary Outcomes (2)

• Digit Identification

  The investigators will measure the behavioral accuracy of listeners identifying digits in a continuous stream of monosyllabic words. In a roughly two-minute run, about 30 digits are presented and listeners are tasked with immediately identifying each one as they are presented. The target stream can be stationary or moving in space, and the masker speech stream can be stationary at the front loudspeaker or diffused around the front speaker (i.e., played from multiple speakers). For static or fixed spatial separations between target and masker (between 0° and 90°), the digit identification accuracy is in percent correct. For multiple spatial separations, the investigators can derive a psychometric curve from which the investigators can extract the spatial separation needed to get a desired percent correct, like 75%, and the investigators call this the Spatial Segregation Boundary (in degrees).

  Acute: Outcome measures are collected with and without treatment over multiple sessions spanning roughly 2 weeks.

• Neural Segregation

  Using two neural entrainment models (forward and backward), the investigators will measure the probability that the brain is able to encode attended speech during a speech-on-speech task. Listeners are tasked with identifying digits during the task carried by either the male or female speaker. The neural entrainment models will be conducted for each spatial separation (between 0° and 90°), from which the investigators will derive a single probability metric for fixed spatial separations or for multiple locations, revealing a neurometric curve. From the neurometric curve, the investigators can extract the spatial separation needed to get a desired percent correct, like 75%, and the investigators call this the Neural Spatial Segregation Boundary (in degrees).

  Acute: Outcome measures are collected with and without treatment over multiple sessions spanning roughly 2 weeks.

Secondary Outcomes (3)

• Minimum Audible Angle (MAA)

  Acute: Outcome measures are collected with and without treatment over multiple sessions spanning roughly 2 weeks.

• Speech Localization Error

  Acute: Outcome measures are collected with and without treatment over multiple sessions spanning roughly 2 weeks.

• Fixed Spatial Release from Masking

  Acute: Outcome measures are collected with and without treatment over multiple sessions spanning roughly 2 weeks.

Other Outcomes (5)

• Pure-tone Air Threshold (PTac)

  Pre-treatment: Outcomes are collected on first day of study without treatment

• Bone Conduction Threshold (PTbc)

  Pre-treatment: Outcomes are collected on first day of study without treatment

• Wideband Tympanometry (Equivalent Ear Canal Volume)

  Pre-treatment: Outcomes are collected on first day of study without treatment

Study Arms (3)

Older listeners with hearing loss

EXPERIMENTAL

Test group, tested with and without the intervention (openMHA device) fit to their audiometric profile.

Device: Open-source master hearing aid

Older listeners with normal hearing

NO INTERVENTION

Control group, no intervention.

Younger listeners with normal hearing

NO INTERVENTION

Control group, no intervention.

Interventions

Open-source master hearing aid DEVICE

The investigators will administer the intervention by fitting the device to the participant's audiometric profile. Testing will be counter-balanced across conditions with half the conditions requiring no intervention and the other half with the intervention.

Also known as: openMHA

Older listeners with hearing loss

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Bilateral sensorineural hearing losses within the mild-to-moderately severe range as indicated by pure tone air- and bone-conduction audiometry and screening (Y-226 Hz, Type "A") tympanograms.
• Candidates for hearing aids or experienced users.
• Fluent speaker of English as speech testing will be in English.
• MoCA (Montreal Cognitive Assessment; Nasreddine et al., 2005) score of \> 22. This cut point has been used frequently in investigations of aging and will better ensure that cognitive related problems will not restrict the abilities of subjects to perform the study tasks.

You may not qualify if:

• Head trauma
• Traumatic brain injury
• Epilepsy
• Seizures
• Other neurological disorders
• Otologic surgical procedures
• Actively fluctuating hearing loss
• Acute Meniere's disease
• Labyrinthitis
• Conductive hearing loss
• Use of ototoxic medications

Sponsors & Collaborators

• University of South Florida: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

USF Research Park BPB, 3802 Spectrum Boulevard, Suite 210C

Tampa, Florida, 33612, United States

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Orientation, Spatial

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spatial Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be told which hearing aid processing is active during testing.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: April 22, 2024
• Study Start: November 16, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

US (1)