Assessing Speech Perception and Amplification Benefit During Infancy

NCT05653999 | Completed FDA Device

• 1 other identifier: 22-2169
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this project is to compare aided and unaided speech discrimination among infants with hearing loss and a cohort of infants with typical hearing. Working Hypothesis: Among this group of infants with hearing loss, performance will be significantly better when infants are tested while using amplification (i.e., aided condition) compared to when tested without amplification (i.e., unaided condition). Infants fit with optimally programmed amplification will perform similarly to the infants with typical hearing on speech discrimination tasks.

Conditions

Hearing Loss; Children With Hearing Differences; Amplification; Speech Perception

Outcome Measures

Primary Outcomes (1)

• Behavioral Speech Perception

  To measure speech perception ability, infants are trained to complete a task in response to a change in a speech sound played over a speaker. Scores are given in d' (or equivalent) and are calculated from both true and false responses. Scores can range from 0.97 and 3.00. Scores above 1.2 are considered significantly above chance indicating successful perception of speech contrasts. To separate issues such as speech discrimination abilities versus proper conditioning, if a child is unable to discriminate a speech contrast (e.g., /ba-da/ or /sa-sha/) testing will transition to the 'easier' speech contrast /a-i/. If the child can discriminate between /a-i/, the investigators will repeat the previously tested contrast. Upon completion of this contrast the next contrast in will be assessed based on randomization ordering. If either contrast was not assessed/the child did not reach criterion, the participant will be rescheduled within 1 month, pending subject factors.

  Through study completion, up to 6 weeks pending subject factors (e.g., fatigue, otitis media)

Secondary Outcomes (1)

• Aided Behavioral Speech Perception Improvement

  Through study completion, up to 6 weeks pending subject factors (e.g., fatigue, otitis media)

Study Arms (2)

Normal Hearing

Group 1 will consist of approximately 20 infants with normal hearing. This cohort will have passed their newborn hearing screenings and will pass audiologic measurements on the day of testing. Audiologic measurements include tympanometry to determine middle ear function and otoacoustic emissions testing to determine cochlear integrity.

Hearing Loss

Group 2 will consist of approximately 20 infants with diagnosed bilateral sensorineural hearing loss ranging from mild to severe. These infants will also pass audiologic measures on the day of testing (tympanometry as described in group 1), currently use bilateral air-conduction hearing aids, and are enrolled in early intervention services.

Device: Hearing Aids

Interventions

Hearing Aids DEVICE

Hearing aids will be used by infants with a diagnosed sensorineural hearing loss.

Hearing Loss

Eligibility Criteria

• Age: 6 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants between 6 and 36 months of age (inclusively) will be be enrolled in either the normal hearing or hearing loss cohort based on hearing status. Infants will be recruited from the community as well as through established clinical relationships with the principal investigator at Children's Hospital Colorado Audiology Centers.

You may qualify if:

• Children between the ages of 6 months and 36 months (inclusive) at the time of enrollment.
• English is the primary spoken language in the home
• Demonstrated ability to complete a conditioned head turn via visual reinforcement audiometry (VRA)
• If normal hearing
• Normal hearing sensitivity bilaterally
• If Hearing Loss
• Children with diagnosis of bilateral sensorineural hearing ranging from mild to severe
• Children currently using hearing aids
• Children currently enrolled in intervention

You may not qualify if:

• Children born earlier than 35 weeks gestation
• Children with abnormal tympanometry on the day of testing
• Children with concerns of secondary disabilities
• Children with Auditory Neuropathy
• Concerns of hearing loss in normal hearing children

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Sonova AG: collaborator

Study Sites (1)

University of Colorado School of Medicine - Speech Perception Over Time Lab

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Sensory Aids

Study Officials

• Kristin M Uhler, PhD

  University of Colorado School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 16, 2022
• Study Start: March 10, 2023
• Primary Completion: May 28, 2025
• Study Completion: May 28, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-05

Locations

US (1)