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Complication from hearing aid mold material: a case report and review of legal matters

Jason A Meyers1, Farhad Ardeshirpour, Christopher W Hilton

  • 1Department of Otolaryngology-Head and Neck Surgery, University of Minnesota, Minneapolis, MN, USA.

American Journal of Otolaryngology
|October 1, 2013
PubMed

Insights

Ear mold foreign bodies are a rare complication of hearing aid fitting. This case highlights the need for improved practices to prevent these occurrences.

Area of Science:

  • Otolaryngology
  • Audiology
  • Medical Device Complications

Background:

  • Ear mold impression foreign bodies are an uncommon complication associated with hearing aid use.
  • While few cases are documented, the true incidence may be underestimated.
  • Pre-existing tympanic membrane perforations can increase risk.

Observation:

  • A 77-year-old male with a history of tympanic membrane perforations presented with a foreign body in the middle ear, originating from an ear mold impression.
  • Surgical intervention was necessary for removal of the foreign body.

Findings:

  • The case underscores the potential for hearing aid components to become lodged in the middle ear.
  • The interaction between patients, hearing aid dispensers, and otolaryngologists is influenced by state and federal regulations.

Implications:

  • Implementing preventative measures during hearing aid fitting is crucial to reduce the incidence of ear mold foreign bodies.
  • Further research into the actual incidence and risk factors is warranted.
  • Clearer guidelines and improved communication among healthcare providers and device sellers may enhance patient safety.

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