Assessing Speech Perception and Amplification Benefit During Infancy

Study Overview
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Brief Summary
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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.

Official Title
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Assessing Speech Perception and Amplification Benefit During Infancy

Conditions
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Hearing Loss, Children With Hearing Differences, Amplification, Speech Perception

Intervention / Treatment
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* Device: Hearing Aids


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal Hearing<br>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<br>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<br>* Hearing aids will be used by infants with a diagnosed sensorineural hearing loss.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 1.28 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aided Behavioral Speech Perception Improvement | Scores are measured from 0 to 2.03. Higher scores indicate greater benefit from hearing aid use in the hearing loss cohort. | Through study completion, up to 6 weeks pending subject factors (e.g., fatigue, otitis media) |