Management of Pediatric Single-Sided Deafness After Changes in US Food and Drug Administration (FDA) Indications for Unilateral Cochlear Implantation

Sunday, September 29, 2024

2:30 PM – 2:36 PM EDT

Location: MBCC, 225

Disclosure(s):

Sainiteesh Maddineni, BS:

faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.

Alan G. Cheng, MD:

faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.

Kay W. Chang, MD:

faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.

Introduction: In July 2019, the FDA approved unilateral cochlear implantation (CI) in children with single-sided deafness (SSD) ages 5 and older. Here we evaluate how workup and management of children evolved after the approval.

Methods: We retrospectively reviewed 190 cases of children ages 0-21 years with SSD who received imaging via MRI and/or CT at our institution from January 2014 to August 2021. SSD was defined as unilateral severe-to-profound sensorineural hearing loss with normal hearing in the contralateral ear. We collected data on demographics, imaging, and hearing interventions.

Results: In our cohort of 190 children, 76 (40%) were imaged with MRI, 83 (43.7%) CT, and 31 (16.3%) both. Of the 190 children, 180 had records of their date of initial imaging for SSD. There were 95 (52.8%) children less than 5 years at initial imaging, and 85 (47.2%) were 5 years or older. There were 140 (77.8%) children imaged before July 2019 and 40 (22.2%) after July 2019.

Significantly more children were imaged with MRI after July 2019 (82.5% [33/40]) compared to before (49.3% [69/140], p < 0.001). Amongst children under 5 years of age, 95.2% (20/21) were imaged with MRI after 2019 while 47.3% (35/74) were imaged before 2019 (p < 0.001). After July 2019, a significantly higher proportion of children 5 years of age or older imaged with MRI were diagnosed with cochlear nerve deficiency (92.3% [12/13]) compared to before July 2019 (58.8% [20/34], p = 0.028).

There was no significant increase in the rate of CI after the change in FDA indications (2.1% [3/140] before vs 5.0% [2/40] after, p = 0.33). However, there was a significant increase in the proportion of all children imaged after July 2019 who received bone conduction hearing devices (BCHD) (8.6% [12/140] before July 2019 vs 30% [12/40] after July 2019, p < 0.001).

Conclusions: Significantly more children were imaged with MRI after the FDA approval, especially children under 5 years of age, suggesting more candidates were worked up for possible CI. Notably, the rate of CI did not substantially rise at our institution after the FDA approval of unilateral CI in children with SSD ages 5 and older. However, the proportion of children using BCHD increased.

Presenting Author(s)

Sainiteesh Maddineni, BS

Medical Student
Stanford University School of Medicine
San Ramon, CA, United States

Disclosure(s):
faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.

Co-Author(s)

Kristina M. Ward, AuD, PhD, CCC-A

Pediatric Audiologist & Research Associate
Stanford University
Palto Alto, CA, United States

Disclosure information not submitted.
AC

Alanna Coughran

Disclosure information not submitted.
AC

Alan G. Cheng, MD

Professor
Stanford University
Palo Alto, CA, United States

Disclosure(s):
faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.
KC

Kay W. Chang, MD

Professor
Stanford University
Stanford, CA, United States

Disclosure(s):
faculty for this accredited education activity has no relationship(s) with ineligible companies to disclose.

Senior Author(s)

Iram N. Ahmad, MD, MME

Assistant Professor
Stanford University
Palo Alto, CA, United States

Disclosure information not submitted.