NCT05653999

Assessing Speech Perception and Amplification Benefit During Infancy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 36 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 6 Months – 36 Months
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	Hearing Aids	Hearing aids will be used by infants with a diagnosed sensorineural hearing loss.

Timeline

• Start date: 2023-03-10
• Primary completion: 2025-05-28
• Completion: 2025-05-28
• First posted: 2022-12-16
• Last updated: 2025-06-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study