Abstract
Ear mold impression middle ear foreign bodies are a rare complication of hearing aid fitting. Only a small number of cases have been reported; however, the actual incidence is unknown and likely much higher than expected. We present the case of a 77-year-old man with a history of preexisting tympanic membrane perforations who presented with an ear mold impression middle ear foreign body that required surgical removal. We explore the state and federal laws that guide the interaction between patients, hearing aid sellers and otolaryngologists. We highlight steps that can be taken to reduce the incidence of this complication.
1
Introduction
Hearing impairment affects nearly 30 million Americans . When medical and surgical interventions are unable correct the hearing loss, amplification with hearing aids is often an effective method for auditory rehabilitation and improved quality of life. Most hearing aids require a hearing aid mold that is properly fit to the external auditory meatus and canal. There are several reports in the literature of complications related to ear mold impression material . Many of these cases occurred when there was preexisting deformity or ear disease. The Food and Drug Administration (FDA) mandates that hearing aid dispensers advise patients to consult with a licensed physician when abnormal ear anatomy or other conditions are identified; however, patients have the right to waive this requirement . Audiologists and hearing aid dispensers are required by state law to have the ability to examine the ear to determine if it is safe to make a hearing aid mold . This report examines the case of an ear mold impression foreign body with a focus on state and federal laws governing all sellers of hearing aids.
2
Case report
A 77-year-old man with a history of tympanic membrane perforations presented to our clinic with right-sided otalgia, pulsatile tinnitus, ear fullness and intermittent otorrhea several weeks following hearing aid mold fitting. The patient described severe pain and popping sound at the time of ear mold material injection. He was initially evaluated by a general otolaryngologist who identified the foreign material in the right ear and was unable to remove it in the clinic. The patient was subsequently referred to our tertiary otology clinic for evaluation. Our exam demonstrated bluish-white foreign material medial to the right tympanic membrane. There was a large perforation present and the foreign material was posterior to the malleus and encasing the ossicles.
Audiogram demonstrated a moderate–severe conductive hearing loss in the right ear with pure tone average (PTA) of 68 dB and speech recognition score (SRS) of 68% at 100 dB. The left ear had a mixed moderate-to-severe hearing loss with PTA of 48 dB and SRS of 92% at 90 dB ( Fig. 1 A ). Tympanograms were flat bilaterally. Computed tomography of the right temporal bone revealed foreign material in the middle ear encasing the ossicles ( Fig. 2 ).
The patient elected to undergo surgical removal of the cast. A post-auricular approach was selected and the tympanic membrane remnant was elevated in the usual manner. The mold was found to fill the middle ear space and surrounded the ossicles ( Fig. 3 ). The mold was cut into pieces with a sickle knife and microscissors. In order to remove the casting between the stapes and facial nerve the stapes was dislocated creating a perilymphatic leak. The stapes was rotated back into the window and a fascia graft was used to cover the footplate margins and the leak resolved. Post-operative course was uneventful and the patient’s symptoms of pain resolved. One month post-operative audiogram demonstrated the right ear with PTA of 53 dB and SRS of 60% at 95 dB and the left ear with PTA of 45 dB and SRS of 100% at 85 dB ( Fig. 1 B).
2
Case report
A 77-year-old man with a history of tympanic membrane perforations presented to our clinic with right-sided otalgia, pulsatile tinnitus, ear fullness and intermittent otorrhea several weeks following hearing aid mold fitting. The patient described severe pain and popping sound at the time of ear mold material injection. He was initially evaluated by a general otolaryngologist who identified the foreign material in the right ear and was unable to remove it in the clinic. The patient was subsequently referred to our tertiary otology clinic for evaluation. Our exam demonstrated bluish-white foreign material medial to the right tympanic membrane. There was a large perforation present and the foreign material was posterior to the malleus and encasing the ossicles.
Audiogram demonstrated a moderate–severe conductive hearing loss in the right ear with pure tone average (PTA) of 68 dB and speech recognition score (SRS) of 68% at 100 dB. The left ear had a mixed moderate-to-severe hearing loss with PTA of 48 dB and SRS of 92% at 90 dB ( Fig. 1 A ). Tympanograms were flat bilaterally. Computed tomography of the right temporal bone revealed foreign material in the middle ear encasing the ossicles ( Fig. 2 ).
