Outcomes in Children With Pre-operative Residual Hearing

NCT03379870 | Completed Results FDA Device

• 1 other identifier: 17-2360
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

High Frequency Sensorineural Hearing Impairment; Hearing Disorders in Children

Keywords

cochlear implant; electric acoustic stimulation; EAS; hearing loss; pediatric

Outcome Measures

Primary Outcomes (2)

• Mean CNC Word Scores

  The Consonant Nucleus Consonant (CNC) word list is established as a standard test of speech perception outcomes. Results for EAS and FES Arms at 12 months post stimulation will be compared. Lower scores indicate a poorer outcome and higher scores a better outcome. Scale 0 - 100%

  12 months post stimulation

• Mean BKB-SIN SNR-50 Scores

  Sentences and babble will be presented from the same speaker. An average score known as the SNR-50 will be obtained in both conditions. The SNR-50 score is an estimate of the signal-to-noise ratio associated with 50% correct based on word-level scoring. Results for EAS and FES listeners at 12 months post stimulation will be compared. In this test, lower scores indicate a better outcome and higher scores a poorer outcome. Scores range from -6 dB to +21 dB.

  12 months post-stimulation

Secondary Outcomes (4)

• Mean Pediatric SSQ Scores

  Baseline, 12 months post-stimulation

• Receptive Language Scores

  12 months post-stimulation

• Articulation Scores

  12 months post-stimulation

• Expressive Language Scores

  12 months post-stimulation

Study Arms (2)

EAS Arm

EXPERIMENTAL

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.

Device: Electric Acoustic Speech Processor: Electric-acoustic stimulation fitting

FES Arm

EXPERIMENTAL

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

Device: Electric Acoustic Speech Processor: Full-electric stimulation fitting

Interventions

Electric Acoustic Speech Processor: Electric-acoustic stimulation fitting DEVICE

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

Also known as: MED-EL SONNET EAS, MED-EL SONNET 2 EAS

EAS Arm

Electric Acoustic Speech Processor: Full-electric stimulation fitting 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.

Also known as: MED-EL SONNET EAS, MED-EL SONNET 2 EAS

FES Arm

Eligibility Criteria

• Age: 60 Months - 215 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Med-El Corporation: collaborator

Study Sites (1)

The Children's Cochlear Implant Center at UNC

Durham, North Carolina, 27713-6102, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Lisa Park, AuD
• Organization: The Children's Cochlear Implant Center at UNC

lisa_park@med.unc.edu

919-419-1449

Study Officials

• Lisa Park, AuD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: December 20, 2017
• Study Start: May 25, 2018
• Primary Completion: December 14, 2023
• Study Completion: December 14, 2023
• Last Updated: October 15, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)