Faculty Collaboration Database

Patient Outcomes in Magnet-Based Implantable Auditory Assist Devices. JAMA Otolaryngol Head Neck Surg 2014 Jun;140(6):513-20

Date

04/26/2014

Pubmed ID

24763485

DOI

10.1001/jamaoto.2014.484

Scopus ID

2-s2.0-84903537445 (requires institutional sign-in at Scopus site)   42 Citations

Abstract

IMPORTANCE: Magnet-based implantable auditory assist devices (MIAADs) are a recent development in bone-anchored hearing devices. This report increases the number of children studied with specific outcome criteria and provides detailed solutions to avoid device use difficulties in other centers considering this device.

OBJECTIVE: To assess hearing thresholds, use rates, and complications in children implanted with a MIAAD for conductive hearing loss.

DESIGN, SETTING, AND PARTICIPANTS: Retrospective analysis of children implanted with an MIAAD at an ambulatory care quaternary referral center since the Food and Drug Administration approved the Sophono device (Sophono Inc) for use in the United States (May 2011 through January 2013). Ten pediatric patients were implanted for conductive hearing loss (14 ears; mean age at implantation, 9 years [range, 3.8-17.2 years]). Diagnoses included aural atresia (n = 7) and chronic ear disease and cholesteatoma (n = 3).

INTERVENTIONS: Implantation of MIAAD and management of skin complications.

MAIN OUTCOMES AND MEASURES: Demographics, hearing thresholds, use rates, and complications were assessed.

RESULTS: After fitting with the magnetic baseplate and sound processor, the mean (SD) aided pure-tone average was 20.2 (6.0) dB hearing level (HL), with a mean (SD) functional gain of 39.9 (12.4) dB HL. There were no surgical complications. Negative outcomes were assessed following fitting of the sound processor. The skin complication rate was 35.7%, including skin breakdown (n = 2) and pain and erythema (n = 5), which resulted in decreased use of the device for these patients. Intervention included decreasing the magnet strength, graduated wearing schedule, antibiotic ointment, barrier protection, and reoperation for well widening with Alloderm (LifeCell Corporation) placement. Patients without skin complications are consistent users of their device, with an average daily use of 8 to 10 hours.

CONCLUSIONS AND RELEVANCE: The MIAAD device has equivalent levels of hearing restoration to other previously described methods of intervention for children with conductive hearing loss. This early report indicates high rates of skin difficulties and a need for improved methods of implantation, magnetic baseplate fitting, and device use. We suggest decreased magnet strength at the initial fitting, a graduated wearing schedule, caution with patients who have a history of skin issues from a bone-anchored hearing aid or multiple surgical procedures, and parent counseling regarding potential skin irritation.

Author List

O'Niel MB, Runge CL, Friedland DR, Kerschner JE

Authors

David R. Friedland MD Associate Director, Director, Chief, Professor in the Otolaryngology department at Medical College of Wisconsin
Joseph E. Kerschner MD Provost, Executive Vice President, Dean, Professor in the School of Medicine Administration department at Medical College of Wisconsin
Christina Runge PhD Associate Provost, Chief, Professor in the Otolaryngology department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Adolescent
Bone Conduction
Child
Child, Preschool
Cochlear Implants
Congenital Abnormalities
Ear
Electromagnetic Phenomena
Female
Hearing Loss, Conductive
Hearing Loss, Sensorineural
Humans
Magnetics
Male
Prosthesis Design
Prosthesis Implantation
Retrospective Studies