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| Name | Class |
|---|---|
| Sonova AG | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hearing Aids | Device | Hearing aids will be used by infants with a diagnosed sensorineural hearing loss. |
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| 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 1.2 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. | Through study completion, up to 6 weeks pending subject factors (e.g., fatigue, otitis media) |
| 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) |
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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
Exclusion Criteria:
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Infants between 6 and 36 months of age (inclusively) will be be enrolled in either the normal hearing or hearing loss cohort based on hearing status. Infants will be recruited from the community as well as through established clinical relationships with the principal investigator at Children's Hospital Colorado Audiology Centers.
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| Name | Affiliation | Role |
|---|---|---|
| Kristin M Uhler, PhD | University of Colorado School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado School of Medicine - Speech Perception Over Time Lab | Aurora | Colorado | 80045 | United States |
The investigators will review requests for de-identified data and review with appropriate regulatory bodies.
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D006310 | Hearing Aids |
| ID | Term |
|---|---|
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D012682 | Sensory Aids |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |