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Outcomes in Children With Pre-operative Residual Hearing

NCT03379870 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-10-15

Study results available
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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.

Conditions

  • High Frequency Sensorineural Hearing Impairment
  • Hearing Disorders in Children

Interventions

DEVICE

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,

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.

Sponsors & Collaborators

  • Med-El Corporation

    collaborator INDUSTRY

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Lisa Park, AuD · University of North Carolina, Chapel Hill

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Months
Max Age
215 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-25
Primary Completion
2023-12-14
Completion
2023-12-14
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03379870 on ClinicalTrials.gov