Assessing Speech Perception and Amplification Benefit During Infancy

University of Colorado Denver (CU Denver)

Status: Completed

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

Treatments: Device: Hearing Aids

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05653999

22-2169

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 6 to 36 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

36 participants in 2 patient groups

Normal Hearing

Description:

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

Description:

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.

Treatment:

Device: Hearing Aids