Assessing Speech Perception and Amplification Benefit During Infancy

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.

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Key information

Conditions

Hearing Loss Amplification Children With Hearing Differences Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Speech Perception

Age range

6 month–36 month

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hearing aids

Device

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

Primary outcomes

Behavioral Speech Perception

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

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.

Secondary outcomes

Aided Behavioral Speech Perception Improvement

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

Scores are measured from 0 to 2.03. Higher scores indicate greater benefit from hearing aid use in the hearing loss cohort.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

Sonova AG

Registry information

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Dec 16, 2022
Registry last updated: Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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