Outcomes in Children With Pre-operative Residual Hearing
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Other Indications, Other Indications, Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 6/1/2018 |
| Start Date: | May 25, 2018 |
| End Date: | December 2021 |
Outcomes in Children With Cochlear Implants and Pre-Operative Residual Hearing: Electric Only and Electric-Acoustic Stimulation
Purpose: Routine clinical care and pilot study data has shown evidence of postoperative
hearing preservation in pediatric cochlear implant (CI) recipients. The primary aim of this
study is to investigate speech perception performance in pediatric CI recipients with
functional pre-operative hearing.
Participants: Two cohorts of CI recipients aged 6 through 17 years who had pre-operative low
frequency residual hearing. Subjects in Arm 1 will present with a post-operative low
frequency pure tone average (125, 250, and 500 Hz) of ≤ 75 dB HL, and those in Arm 2 will
present with a post-operative low frequency pure tone average (LFPTA) that exceeds 75 dB HL.
Procedures (methods): Subjects will complete speech perception and quality of life testing
during post-operative intervals. Subjects in Arm 1 will be evaluated with the cochlear
implant alone (CI-alone) and with combined electric-acoustic stimulation (EAS). Subjects in
Arm 2 will be evaluated with the CI-alone.
hearing preservation in pediatric cochlear implant (CI) recipients. The primary aim of this
study is to investigate speech perception performance in pediatric CI recipients with
functional pre-operative hearing.
Participants: Two cohorts of CI recipients aged 6 through 17 years who had pre-operative low
frequency residual hearing. Subjects in Arm 1 will present with a post-operative low
frequency pure tone average (125, 250, and 500 Hz) of ≤ 75 dB HL, and those in Arm 2 will
present with a post-operative low frequency pure tone average (LFPTA) that exceeds 75 dB HL.
Procedures (methods): Subjects will complete speech perception and quality of life testing
during post-operative intervals. Subjects in Arm 1 will be evaluated with the cochlear
implant alone (CI-alone) and with combined electric-acoustic stimulation (EAS). Subjects in
Arm 2 will be evaluated with the CI-alone.
As children with more residual hearing are receiving cochlear implants (CIs), there is an
opportunity to preserve that hearing and provide combined electric and acoustic stimulation
(EAS). The primary aim of this study is to investigate speech perception performance in
pediatric CI recipients with functional pre-operative hearing. Specifically, the
investigators intend to compare speech understanding using EAS and traditional full electric
stimulation.
While hearing preservation rates are good, they are not guaranteed. Children with progressive
hearing loss may continue to lose hearing, even if they maintain some residual hearing
immediately after surgery. As a secondary aim, the investigators intend to study outcomes in
children who do not maintain residual hearing and are fit with traditional CI programming
methods. Children with more residual hearing are being implanted, and this study design
allows validation of outcomes in both populations.
Subject enrollment will occur on the initial stimulation date. Those who have maintained a
low frequency hearing average of 75 dB HL or better will be fit with a SONNET EAS device
using combined acoustic and electric stimulation. Those who have not maintained low frequency
hearing will be fit with a SONNET EAS device using electric stimulation only. Subjects will
be followed at regular intervals throughout the year duration of the study and will be tested
on measures of speech understanding in quiet, speech understanding in noise, quality of life,
and discrimination of prosody or pitch changes.
opportunity to preserve that hearing and provide combined electric and acoustic stimulation
(EAS). The primary aim of this study is to investigate speech perception performance in
pediatric CI recipients with functional pre-operative hearing. Specifically, the
investigators intend to compare speech understanding using EAS and traditional full electric
stimulation.
While hearing preservation rates are good, they are not guaranteed. Children with progressive
hearing loss may continue to lose hearing, even if they maintain some residual hearing
immediately after surgery. As a secondary aim, the investigators intend to study outcomes in
children who do not maintain residual hearing and are fit with traditional CI programming
methods. Children with more residual hearing are being implanted, and this study design
allows validation of outcomes in both populations.
Subject enrollment will occur on the initial stimulation date. Those who have maintained a
low frequency hearing average of 75 dB HL or better will be fit with a SONNET EAS device
using combined acoustic and electric stimulation. Those who have not maintained low frequency
hearing will be fit with a SONNET EAS device using electric stimulation only. Subjects will
be followed at regular intervals throughout the year duration of the study and will be tested
on measures of speech understanding in quiet, speech understanding in noise, quality of life,
and discrimination of prosody or pitch changes.
Inclusion Criteria:
- Aged 6 through 17 years
- Spoken English as the primary language (speech perception testing conducted in
English).
- Recipient of a MED-EL SYNCHRONY Cochlear Implant device.
- Pre-operative LFPTA of ≤ 75 dB HL.
- Willing and able to participate in study procedures.
- Cognition within normal limits as measured by the Leiter-R.
- Realistic parental/patient expectations.
- Language skills no more than two standard deviations below the mean per the OWLS II as
measured within the 6 months prior to enrollment.
Exclusion Criteria:
- Inability to perform open set speech perception due to oral motor delays.
- Inability to perform test battery due to behavior or cognitive impairment as measured
by the Leiter-R.
- Unwilling or unable to participate in study procedures.
- Cochlear nerve deficiency.
- Anatomical considerations that necessitated surgical modifications such as
ossification, incomplete insertion, or placement in scala vestibuli.
We found this trial at
1
site
5501 Fortunes Ridge Drive
Durham, North Carolina 27713
Durham, North Carolina 27713
Principal Investigator: Lisa Park, AuD
Phone: 919-419-1449
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