Foreign Body Complications in Ears due to Mishandled Hearing Aid Fitting and Proposed Clinical Guidelines to Address the Complications

BACKGROUND: South Korea has one of the world’s fastest aging populations and is witnessing increased age-related hearing impairment cases as well as an increase in the number of hearing aid users. The aim of this study was to analyze complications caused by hearing aid mold materials. In addition, we hope to raise awareness of the harm and danger that inexperienced hearing aid providers can cause to patients. METHODS: We retrospectively reviewed the medical records of 11 patients who were diagnosed with hearing aid mold material as a foreign body in the ear at a tertiary center between 2016 and 2020. The following data were analyzed: symptoms, endoscopic findings, audiometry, temporal bone CT images, treatment methods, and complications after removal. The currently available literature was also reviewed to develop clinical guidelines, to identify the systematic weaknesses in the South Korean hearing aid market, and to identify policies that warrant better quality control. RESULTS: Among the 11 cases, 9 were restricted to the external auditory canal, all of which were successfully removed under endoscopy with minor complications. Two cases with middle ear involvement resulted in infection and thus required surgical removal with mastoidectomy. The average age of these patients was 76.4, and all patients received their molding procedure at private hearing aid shops without an otolaryngologist’s examination. CONCLUSION: Thorough patient history-taking and otologic examination must be performed to identify patients at higher risk of complications. Such patients should be referred to an otolaryngologist. If a patient exhibits alarming symptoms, early referral is critical since prompt surgery can minimize complications. A CT scan is highly recommended to determine an optimal approach for foreign body removal. Systematic and regulatory changes in hearing aid dispensers, such as requiring apprenticeship, raising the required level of education, and legally mandating referrals, can help reduce these complications.