Outcomes in Children With Pre-operative Residual Hearing

Completed · Not applicable

Conditions studied: High Frequency Sensorineural Hearing Impairment, Hearing Disorders in Children

In brief

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.

Key facts

Study ID

NCT03379870

Run by

University of North Carolina, Chapel Hill

People needed

28

Starts

2018-05-25

Expected to finish

2023-12-14

Last updated by the study team

2024-10-15

Who can join

Age: 5 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Children's Cochlear Implant Center at UNC — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.