Assessing Speech Perception and Amplification Benefit During Infancy
Key facts
- Who runs it
- University of Colorado, Denver
- Where
- Aurora, United StatesSee the site
- Trial code
- Status
- Completed
- People taking part
- 36 people enrolled
- Started
- 10 Mar 2023
- Ended
- 28 May 2025
- Type of study
- Observational, 2 groups
- Treatments tested
- Hearing Aids
- Record updated
- 4 June 2025
Who can take part
- Age
- 6 months to 36 months
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- 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
Where in United States
- University of Colorado School of Medicine - Speech Perception Over Time LabAurora, United States
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- 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.
Treatment: Hearing Aids
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 4 June 2025