AM ER IC AN JOURNAL OF OT OLA RYNGOLOGYH E A D A N D NE CK M E D ICI N E AN D S U RGE RY 3 8 (2 0 1 7) 1 08 1 1 1

Available online at www.sciencedirect.com

ScienceDirect
www.elsevier.com/locate/amjoto

Hearing aid silicone impression material as a foreign

body in the middle ear,

Hyun-Min Lee, MD a , Keun-Ik Yi, MD b , Jae-Hoon Jung, MD a , Il-Woo Lee, MD, PhD a,
a
Department of Otorhinolaryngology Head and Neck Surgery, Pusan National University School of Medicine, Pusan National University
Yangsan Hospital, Yangsan, Republic of Korea
b
Department of Otorhinolaryngology Head and Neck Surgery, Pusan National University School of Medicine, Pusan National University
Hospital, Busan, Republic of Korea

ARTI CLE I NFO A BS TRACT

Article history: We report an extremely rare case of hearing aid silicone impression material as a foreign
Received 25 August 2016 body in the middle ear. Symptoms of the patient were otorrhea and vertigo after taking of a
mold impression on his only hearing ear, and the symptoms mimicked chronic otitis
media. A temporal bone CT scan revealed foreign body material in the middle ear and
Eustachian tube. An intact canal wall mastoidectomy with a facial recess approach and type
IV tympanoplasty was performed to remove the silicone impression material. In addition to
the case report, we review the literature regarding impression material foreign bodies.
2016 Elsevier Inc. All rights reserved.

1. Introduction
Fitting a hearing aid usually requires the making of an ear
canal mold, which contributes to the quality of hearing aid.
This procedure usually has no complications. However, a few
cases of a silicone impression material foreign body during
ear mold taking have been reported [16]. We experienced a
case of hearing aid silicone impression material as a foreign
body in the middle ear. We report this case herein, together
with a discussion of similar cases in the literature.
2. Case reports
A 62-year-old male with long standing left-side deafness visited
a secondary referral hospital because of right-side hearing
disturbance for 1 year. He had diabetes and underwent
tympanoplasty on his left ear 6 years prior. A hearing aid for
his right ear was prescribed and silicone impression material
for hearing aid was introduced into his right ear canal at a local
hearing aid shop. A few weeks later, he felt vertigo and otorrhea
in his right ear. After antibiotic treatment at a local hospital,
symptoms were not improved. The patient was referred to a
tertiary referral hospital with suspicion of labyrinthitis
6 months after the trauma. Erythema of the canal wall and
crust with active otorrhea were observed in his right-ear
canal (Fig. 1). Mixed hearing loss was checked on pure tone
audiometry (PTA) on his right side, as there was no residual
hearing on his left side (Fig. 2). A high-resolution temporal bone
computed tomography (CT) scan was performed, and imaging
revealed soft tissue density and high-density materials in the
right middle ear cavity and Eustachian tube (Fig. 3).
One month later, a right intact canal wall mastoidectomy
with a facial recess approach and type IV tympanoplasty was

This manuscript was accepted for a poster presentation at the Annual Congress of Korean Society of Otorhinolaryngology Head and
Neck Surgery in Seoul, South Korea, April 2224, 2016.

The authors have no funding, financial relationships, or conflicts of interest to disclose.

Corresponding author at: Department of Otorhinolaryngology Head and Neck Surgery, Pusan National University School of Medicine,
Pusan National University Yangsan Hospital, Geumo-ro 20, Mulgeum-eup. Yangsan, Gyeongnam, Republic of Korea, 50612. Tel.: +82 55
360 2651; fax: +82 55 360 2162.
E-mail address: entgate@pusan.ac.kr (I.-W. Lee).

http://dx.doi.org/10.1016/j.amjoto.2016.09.018
0196-0709/ 2016 Elsevier Inc. All rights reserved.

Downloaded for Mahasiswa KOAS UKDW (mahasiswakoasukdw1@gmail.com) at Universitas Kristen Duta Wacana from ClinicalKey.com by Elsevier on April 23, 2017.
For personal use only. No other uses without permission. Copyright 2017. Elsevier Inc. All rights reserved.
 AM ER IC AN JOURNAL OF OT OLARYNGOLOGYH E A D A N D NE CK M E D IC IN E A ND S U RGE RY 3 8 (2 0 1 7) 1 081 1 1
Fig. 1 The local finding image of right ear canal at the initial
visiting. Crust and erythema of the ear canal were found.
Tympanic membrane was not visible.
performed to remove the foreign material. Before the surgery,
swelling of the right ear canal was worsening. The lower-tone
hearing level of the right ear was poorer than that 1 month
ago. Right ear was the only hearing ear of the patient, and so
informed consent regarding the possibility of hearing loss was
obtained before the surgery. A retroauricular incision was
made for mastoidectomy. Green foreign material was seen
through the ear canal after removing granulation tissue. The
foreign material was not fixed in the middle ear cavity, and an
incision was made in the material. The material was then
removed relatively easily through the ear canal. The shape of
the foreign material was the same as the middle ear cavity
and it reached the Eustachian tube (Fig. 4). There was severe
inflammation and granulation tissue in the middle ear, and
the malleus, incus and suprastructure of the stapes were
damaged. After removing all granulation tissue, a 3 mm
titanium total ossicular replacement prosthesis was placed
for type IV tympanoplasty. Pseudomonas aeruginosa was
cultured from the discharge of the middle ear. The surgery
was performed without any other complications. The post-
Fig. 2 Initial hearing level of the patient. Mixed-type hearing loss was found in his right ear.
Downloaded for Mahasiswa KOAS UKDW (mahasiswakoasukdw1@gmail.com) at Universitas Kristen Duta Wacana from ClinicalKey.com by Elsevier on April 23, 2017
For personal use only. No other uses without permission. Copyright 2017. Elsevier Inc. All rights reserved.
109
operative course was uneventful and the symptoms of
otorrhea and vertigo were relieved.
3. Discussion
Hearing aids are widely used rehabilitation method for
sensorineural or conductive hearing loss patients. In the
Republic of Korea, the overall prevalence of subjective hearing
loss of more than a mild degree was 11.97% according to a
population-based survey. Among the participants that had
significant hearing loss, 24.37% used a hearing aid [7]. The rate
of hearing aid use will increase in the near future. However,
57% of hearing loss patients in Korea bought hearing aids
at hearing-aid providers without consulting an otology
specialist [8].
Producing a hearing aid mold is not difficult for experi-
enced personnel. Though uncommon, complications such as
local skin reaction to the earmold, hearing aid battery erosion
and ingestion, and acoustic trauma with over-amplification
and feedback have been reported [2]. In addition, hearing aid
silicone impression material as a middle ear foreign body has
been reported only rarely. Meyers reported that the incidence
of hearing aid mold as a foreign body in the middle ear was
1:40,000 over 15 years [5]. A surgical procedure for removing
foreign body was needed in such cases. In terms of symp-
toms, accelerated hearing loss and vertigo were frequently
reported. Indeed acute onset of symptoms such as otalgia,
tinnitus, vertigo, nausea and vomiting during the mold-
making process is suggestive of complications. If the patient
experiences significant otalgia or dizziness while the impres-
sion is being taken, the procedure should be stopped
immediately and the patient referred to an otology specialist
[1]. In asymptomatic patients, the onset of symptoms may
take several years. In these patients, symptoms are similar to
characteristic symptoms of chronic otitis media, such as
intractable otorrhea and formation of granulation tissue [3,6].
In our case, the patient had growing granulation tissue,
refractory otorrhea, and chronic dizziness after the mold-
making procedure. High-risk patients such as those having
110 AM ER IC AN JOURNAL OF OT OLA RYNGOLOGYH E A D A N D NE CK M E D ICI N E AN D S U RGE RY 3 8 (2 0 1 7) 1 08 1 1 1

Fig. 3 (A) CT image of the right temporal bone shows high-density materials in the right middle ear cavity and Eustachian
tube. (B) The high-density material in the right middle ear was in contact with the round window on a coronal view CT image.

perforation of the tympanic membrane, retraction pocket,
tympanostomy tubes, or canal wall mastoid cavities should
be closely examined before undergoing an ear mold proce-
dure [6].
Regarding the ear mold material, Ng discussed the long-
term effects of a silicone sheet in the middle ear and reported
no foreign body reaction or chronic inflammatory reaction [9].
In certain cases, the clinical course is silent because the
foreign body does not fill the middle ear cavity and Eusta-
chian tube [6,10]. However, in our case, granulation tissue due
to the foreign body reaction filled the middle ear cavity and
symptoms of chronic inflammation were observed. This was
likely due to complete obstruction of the Eustachian tube and
middle ear cavity.
High-resolution temporal bone CT scan is a useful diag-
nostic tool [1,2]. CT images show the extent of foreign body
material and relationship between the mold-making material
and middle ear structures such as the ossicles, tympanic
membrane, mastoid antrum and mastoid cavity. By reviewing
these images, a surgical treatment plan can be prepared
preoperatively, which will reduce surgical complications. In
the review by Leong, spread of the mold material within the
middle ear cavity was frequently extensive, with 46% of cases
involving the Eustachian tube [4].
Fig. 4 Image of the removed silicone material. The left side
of the material protruded into the Eustachian tube.
Surgical options for removing mold material vary. The
options are meatoplasty, middle-ear exploration, atticotomy,
or tympanoplasty with mastoidectomy [2]. If mold material is
found around the ossicular chain or within the mastoid, a
mastoidectomy with facial recess approach may be necessary
for removal [1]. Proper visualization of the mold material and
surrounding structures is key in surgical treatment and is
associated with the rate of surgical complications and the
outcome of surgery.
According to Leong, 50% of patients recovered without
long-term sequelae. However, 36% of cases experienced
hearing loss as a long-term complication. Complications of
mold material foreign body include foreign body reactions in
the ear canal or mastoid cavity, traumatic tympanic
membrane perforation, ossicular chain discontinuity and
perilymphatic fistula [4]. Furthermore, inadequate visualiza-
tion, inappropriate instrument selection and lack of CT
imaging increase the risk of further damage during surgical
removal [2]. In this case, progressive hearing loss in the only
hearing ear, severe inflammation in the middle ear and
erosion of the ossicular chain were observed.
To reduce this rare complication during impression taking,
hearing aid providers and audiologists should follow the
guidelines for ear mold fitting. These were adequate assess-
ment of a clean external ear canal with complete visualiza-
tion of the TM, placement of a well-positioned protective
otoblock, and atraumatic injection of properly prepared
earmold material. When fitting uncooperative patients or
children, this procedure may be performed in the operation
room setting under general anesthesia with mask ventilation
or sedation [2]. In some countries, guidelines or a certification
program for hearing aid providers was established to reduce
the incidence of complications and maintain hearing aid
quality [2,5,6]. In the Republic of Korea, financial support for
hearing aids has increased recently; however, hearing aid
distribution is dependent on the individual provider. Guide-
lines and education regarding hearing aids should be
strengthened to reduce complications during hearing aid
impression taking.
In conclusion, hearing aid silicone impression material as
a foreign body is a rare complication during impression
taking. However, serious complications such as hearing loss

Downloaded for Mahasiswa KOAS UKDW (mahasiswakoasukdw1@gmail.com) at Universitas Kristen Duta Wacana from ClinicalKey.com by Elsevier on April 23, 2017
For personal use only. No other uses without permission. Copyright 2017. Elsevier Inc. All rights reserved.
 AM ER IC AN JOURNAL OF OT OLARYNGOLOGYH E A D A N D NE CK M E D IC IN E A ND S U RGE RY 3 8 (2 0 1 7) 1 081 1 1
and perilymphatic fistula due to the foreign body can occur.
Acute onset of otalgia or vertigo while impression-taking or
refractory chronic otitis media after hearing-aid fitting is the
essential element in the patient history. Moreover, a high-
resolution temporal bone CT scan is the key diagnostic tool in
such cases. The treatment of choice is surgical removal of the
ear mold foreign body, which should focus on adequate
visualization and effective instrument selection, not a simple
blind removal. An appropriate educational program for
hearing aid providers and immediate consultation with an
otologist if problems occur during impression taking will
minimize the occurrence of severe complications.
Acknowledgments
This manuscript was accepted for a poster presentation at
The Annual Congress of Korean Society of Otorhinolaryngol-
ogy Head and Neck Surgery in Seoul, South Korea, April
2224, 2016.
The authors have no funding, financial relationships, or
conflicts of interest to disclose.
Copyright Transfer: In consideration of the American
Journal of Otolaryngology's reviewing and editing my sub-
mission, Hearing aid silicone impression material as a
foreign body in the middle ear, the authors undersigned
transfers, assign and otherwise convey all copyright owner-
ship to Elsevier Inc. in the event that such work is published
in the American Journal of Otolaryngology.
Downloaded for Mahasiswa KOAS UKDW (mahasiswakoasukdw1@gmail.com) at Universitas Kristen Duta Wacana from ClinicalKey.com by Elsevier on April 23, 2017
For personal use only. No other uses without permission. Copyright 2017. Elsevier Inc. All rights reserved.
111
REFERENCES
[1] Jacob A, Morris TJ, Welling DB. Leaving a lasting impression:
ear mold impressions as middle ear foreign bodies. Ann Otol
Rhinol Laryngol 2006;115:9126.
[2] Kohan D, Sorin A, Marra S, et al. Surgical management of
complications after hearing aid fitting. Laryngoscope 2004;
114:31722.
[3] Lee DH, Cho HH. Otologic complications caused by hearing
aid mold impression material. Auris Nasus Larynx 2012;39:
4114.
[4] Leong SC, Banhegyi G, Panarese A. Serious complications
during aural impression-taking for hearing aids: a case report
and review of the literature. Ann Otol Rhinol Laryngol 2012;
121:51620.
[5] Meyers JA, Ardeshirpour F, Hilton CW, et al. Complication
from hearing aid mold material: a case report and review of
legal matters. Am J Otolaryngol 2013;34:73942.
[6] Suzuki N, Okamura K, Yano T, et al. Silicone impression
material foreign body in the middle ear: Two case reports and
literature review. Auris Nasus Larynx 2015;42:41923.
[7] Cho YS, Choi SH, Park K, et al. Prevalence of otolaryngologic
diseases in South Korea: data from the Korea national health
and nutrition examination survey 2008. Clin Exp
Otorhinolaryngol 2010;3:18393.
[8] Kim KS. Medical Device Market Research Report. Hearing aid
(Vol. 12). Chungbuk, South Korea: Korea Health Industry
Development Institute; 2013.
[9] Ng M, Linthicum Jr FH. Long-term effects of Silastic sheeting
in the middle ear. Laryngoscope 1992;102:1097102.
[10] Awan MS, Iqbal M, Sardar ZI. Iatrogenic insertion of impres-
sion mold into middle ear and mastoid and its retrieval after
9 years: a case report. J Med Case Reports 2007;1:3.