Outcomes in Children With Pre-operative Residual Hearing

NCT ID: NCT03379870

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-25
• Study Completion Date: 2023-12-14

Brief Summary

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 (EAS Arm; electric-acoustic stimulation) 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 (FES Arm; full-electric stimulation) 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 the EAS Arm will be evaluated with combined electric-acoustic stimulation (EAS). Subjects in FES Arm will be evaluated with FES alone.

Detailed Description

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 or SONNET 2 EAS device using combined acoustic and electric stimulation. Those who have not maintained low frequency hearing will be fit with a SONNET EAS or SONNET 2 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.

Conditions

High Frequency Sensorineural Hearing Impairment; Hearing Disorders in Children

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EAS Arm

Subjects who receive a CI and present with a post-operative LFPTA of ≤ 75 dB HL.

Electric Acoustic Speech Processor: Electric-acoustic stimulation (EAS) fitting.

Group Type: EXPERIMENTAL

Electric Acoustic Speech Processor: Electric-acoustic stimulation fitting

Intervention Type: DEVICE

Electric Acoustic Stimulation for children with post-operative residual low frequency hearing averages of 75 dB HL or better,

FES Arm

Subjects with pre-operative low frequency hearing who receive a CI and present with a post-operative LFPTA of > 75 dB HL.

Electric Acoustic Speech Processor: Full-electric stimulation (FES) fitting

Group Type: EXPERIMENTAL

Electric Acoustic Speech Processor: Full-electric stimulation fitting

Intervention Type: DEVICE

Electric Stimulation for children with post-operative residual low frequency hearing averages of 75 dB HL or poorer and pre-operative low frequency hearing averages of 75 dB HL or better.

Interventions

Electric Acoustic Speech Processor: Electric-acoustic stimulation fitting

Electric Acoustic Stimulation for children with post-operative residual low frequency hearing averages of 75 dB HL or better,

Intervention Type: DEVICE

Electric Acoustic Speech Processor: Full-electric stimulation fitting

Electric Stimulation for children with post-operative residual low frequency hearing averages of 75 dB HL or poorer and pre-operative low frequency hearing averages of 75 dB HL or better.

Intervention Type: DEVICE

Other Intervention Names

MED-EL SONNET EAS; MED-EL SONNET 2 EAS; MED-EL SONNET EAS; MED-EL SONNET 2 EAS

Eligibility Criteria

Inclusion Criteria

• Aged 5 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.
• Realistic parental/patient expectations.
• Language skills judged to be adequate enough to perform study tasks.

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
• 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.

• Minimum Eligible Age: 60 Months
• Maximum Eligible Age: 215 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Med-El Corporation

INDUSTRY

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa Park, AuD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

The Children's Cochlear Implant Center at UNC

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

17-2360

Identifier Type: -

Identifier Source: org_study_id