Outcomes in Children With Pre-operative Residual Hearing

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 hearing aid alone (HA-alone) and with combined electric-acoustic stimulation (EAS). Subjects in Arm 2 will be evaluated with the CI-alone.

Study Overview

• Status: Active, not recruiting
• Conditions: High Frequency Sensorineural Hearing Impairment; Hearing Disorders in Children
• Intervention / Treatment: Device: Electric Acoustic Speech Processor: EAS fitting; Device: Electric Acoustic Speech Processor: Electric only fitting

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27713-6102
      • The Children's Cochlear Implant Center at UNC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Subjects who receive a CI and present with a post-operative LFPTA of ≤ 75 dB HL. Electric Acoustic Speech Processor: EAS fitting. They will be evaluated in the EAS condition and the hearing aid (HA) alone condition.	Device: Electric Acoustic Speech Processor: EAS fitting; Electric Acoustic Stimulation for children with post-operative residual low frequency hearing averages of 75 dB HL or better,; Other Names: MED-EL SONNET EAS; MED-EL SONNET 2 EAS
Experimental: Arm 2; 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: Electric only fitting They will be evaluated in the traditional fully electric condition only.	Device: Electric Acoustic Speech Processor: Electric only 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.; Other Names: MED-EL SONNET EAS; MED-EL SONNET 2 EAS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean CNC word scores, comparing EAS and CI-alone conditions at 12 months post stimulation (Arm 1 to Arm 2).	The CNC word list is established as a standard test of speech perception outcomes. Results for EAS and CI-alone conditions at 12 months post stimulation will be compared (Arm 1 to Arm 2). Lower scores indicate a poorer outcome and higher scores a better outcome.	12 months post stimulation
Mean BKB-SIN SNR-50 scores, comparing EAS and CI-alone conditions at 12 months post stimulation (Arm 1 to Arm 2).	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 CI-alone conditions at 12 months post stimulation will be compared (Arm 1 to Arm 2). In this test, lower scores indicate a better outcome and higher scores a poorer outcome.	12 months post-stimulation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Pediatric SSQ scores, comparing Pre-operative and 12 month post stimulation scores in both groups.	The Speech, Spatial, and Qualities of Hearing (SSQ) Scale assesses performance in three domains, hearing speech in quiet and noise environments (9 items), spatial or directional hearing (5 items) and sound qualities (8 items), which address sound segregation and listening effort. Each item is rated on a 11-point scale, with 0 as the lowest possible performance and 10 as the highest.. Domain scores represent an average of item ratings. There is a version for children that will be used for this study. Lower scores indicate a poorer outcome, and higher scores a better outcome.	12 months post-stimulation
Change in percent correct in single word scores in quiet, comparing pre- and post-stimulation scores in both groups	Mean single word scores in quiet, comparing scores obtained pre-operatively and in the primary post-operative listening condition in both groups. Lower scores are a poorer outcome than higher scores.	12 months post-stimulation
Change in speech and language outcomes, comparing Pre- and post-stimulation scores in both groups.	Mean articulation, expressive, and receptive language scores, comparing pre-operative scores to the 12 month test point for both groups. These tests are normed. Scaled scores will be compared. Low scores are indicative of a poorer outcome, and higher scores a better outcome.	12 months post-stimulation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent correct in prosodic identification scores, comparing EAS to CI-Alone conditions in Arm 1 participants	The Question/Answer Task identifies how well a child can perceive changes in pitch that change the meaning of a sentence. Percent correct scores will be obtained and compared. Lower scores indicate a poorer outcome, and higher scores a better outcome.	12 months post-stimulation

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Med-El Corporation
• Investigators: Principal Investigator: Lisa Park, AuD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2018
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: December 15, 2017
• First Submitted That Met QC Criteria: December 15, 2017
• First Posted (Actual): December 20, 2017

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: pediatric; cochlear implant; hearing loss; EAS; electric acoustic stimulation
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Loss; Deafness; Hearing Loss, Sensorineural; Hearing Disorders
• Other Study ID Numbers: 17-2360

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No