Hearing Loss
Conditions
Keywords
sensorineural hearing loss, cochlear implant
Brief summary
The LittlEARS Auditory Questionnaire is designed to assess the development of the auditory behavior in children during the first two (hearing) years. The questionnaire has been validated on children with normal hearing whose native language is German. A comparison was made between North American English speaking children with normal hearing and found that it was consistent with the German data. This study is to validate the questionnaire in children with cochlear implants.
Interventions
None listed
Sponsors
Med-El Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 24 Months
Healthy volunteers
No
Inclusion criteria
General: * Less than or 24 months of age prior to implantation * Cochlear implant candidate deemed by the clinic * To be implanted with a MED-EL cochlear implant PULSARCI100 or SONATATI100 * English as the primary language at home * Realistic expectations of guardians * Willing and available to comply with all scheduled procedures as defined in the protocol Medical: * Good general health status, as judged by Primary Investigator * No contraindications for surgery, in general, or cochlear implant surgery in particular
Exclusion criteria
General: * Prior experience with any cochlear implant system * Older than 24 months at time of implantation Medical: * Severed or non-functional auditory nerve in the ear(s) to be implanted * Cognitive and/or neurological dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Validate the LittleEARS Auditory Questionnaire | 24 months | The LittleEARS auditory questionnaire (LEAQ) uses parent responses to assess auditory behavior in children up to 24 months of age. The questionnaire is scored from 0 to 35 with 0 indicating poorer performance and 35 indicating better performance. There are no subscales for the questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in LEAQ Scale Score of Cochlear Implanted Children Over 24 Months After First CI Fitting | 24 months | The LittleEARS auditory questionnaire (LEAQ) uses parent responses to assess auditory behavior in children up to 24 months of age. The questionnaire is scored from 0 to 35 with 0 indicating poorer performance and 35 indicating better performance. There are no subscales for the questionnaire. This outcome measure is reported as a change on the LEAQ scale from initial CI fitting to 24 months. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cochlear Implant children less than 24 months at time of cochlear implantation | 31 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 7 |
Baseline characteristics
| Characteristic | Cochlear Implant | — |
|---|---|---|
| Age, Continuous | 16.2 months | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 31 participants | — |
| Sex: Female, Male Female | 19 Participants | — |
| Sex: Female, Male Male | 12 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 |
Outcome results
Primary
To Validate the LittleEARS Auditory Questionnaire
The LittleEARS auditory questionnaire (LEAQ) uses parent responses to assess auditory behavior in children up to 24 months of age. The questionnaire is scored from 0 to 35 with 0 indicating poorer performance and 35 indicating better performance. There are no subscales for the questionnaire.
Time frame: 24 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cochlear Implant | To Validate the LittleEARS Auditory Questionnaire | 34.75 units on a scale |
Secondary
Change in LEAQ Scale Score of Cochlear Implanted Children Over 24 Months After First CI Fitting
The LittleEARS auditory questionnaire (LEAQ) uses parent responses to assess auditory behavior in children up to 24 months of age. The questionnaire is scored from 0 to 35 with 0 indicating poorer performance and 35 indicating better performance. There are no subscales for the questionnaire. This outcome measure is reported as a change on the LEAQ scale from initial CI fitting to 24 months.
Time frame: 24 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cochlear Implant | Change in LEAQ Scale Score of Cochlear Implanted Children Over 24 Months After First CI Fitting | 28.78 units on a scale |