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Special Article

Middle ear implants

Gangadhara Somayaji K S, Rajeshwary Aroor1
Department of ENT, Yenepoya Medical College, 1KS Hegde Medical Academy, Mangalore, Karnataka, India

ABSTRACT
Hearing loss is becoming more common in the society living in cities with lot of background noise around, and frequent use of
gadgets like mobile phones, MP3s, and IPods are adding to the problem. The loss may involve the conductive or perceptive pathway.
Majority of the patients with conductive hearing loss will revert back to normal hearing levels with medical and/or surgical treatment.
However, in sensorineural hearing loss, many factors are involved in the management. Though traditionally hearing aids in various
forms are the most commonly used modality in managing these patients, there are some drawbacks associated with them. Implantable
middle ear amplifiers represent the most recent breakthrough in the management of hearing loss. Middle ear implants are surgically
implanted electronic devices that aim to correct hearing loss by stimulating the ossicular chain or middle ear. Of late, they are also
being used in the management of congenital conductive hearing loss and certain cases of chronic otitis media with residual hearing
loss. The article aims to provide general information about the technology, indications and contraindications, selection of candidates,
available systems, and advantages of middle ear implants. (MEI)

Key Words: Envoy system, hearing loss, middle ear implants, vibrant sound bridge

Introduction ameliorate hearing loss. They are designed for individuals

who have serviceable hearing. They serve to overcome the
Implantable middle ear amplifiers represent the most disadvantages of conventional hearing aids such as signal
distortion and biofeedback.[2] By driving the ossicular chain
recent breakthrough in the medical and rehabilitative
directly, the output speaker component of the hearing aids
management of patients with hearing loss. Although
is eliminated, providing a more natural, less distorted
traditional hearing aids are good enough in managing signal to be introduced into the cochlea. This reduces
these patients, their inherent shortcomings and consumer acoustic feedback; the ear remains open eliminating the
dissatisfaction resulted in the evolution of this technology.[1] occlusion effect while enhancing sound quality via the
Implantable hearing devices, as compared to conventional natural resonance of an open ear canal.[3]
hearing aids, are a spectrum of prosthetic devices that
are wholly or partially implanted through surgery to History
Historically, the first clinically available MEIs (by Drs. Suzuki
Access this article online and Yanagihara in Japan) were designed for those with
Quick Response Code: irreversible middle ear conductive/mixed losses.[4] Wilska is
Website:
www.amhs.org
credited with being the first to use electromagnetic induction
to stimulate the middle ear. Iron particles were placed on the
DOI: tympanic membrane of a human subject and stimulated by
10.4103/2321-4848.123049 an electromagnetic coil placed in the ear canal.[4] Since then,
and particularly over the past 30 years, much work has been

Corresponding Author:
Dr. Gangadhara Somayaji K S, Department of ENT, Yenepoya Medical College, Mangalore - 575 018, Karnataka, India.
E-mail: [email protected]

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Somayaji G and Rajeshwary A: Middle ear implants: A monogram

done looking at different sites and the methods of attachment unit attached to the vibratory structure of the middle ear should
of microphone, amplifier, and transducer. The vibrant sound not impair that structure’s ability to vibrate.Another important
bridge was invented by Geoff Ball. A major problem with issue is the anchoring of the device to the ossicular chain.
these implants has been to produce a device that is small Even a little laxity at the interface between the prosthesis and
enough to fit within the confines of the middle ear and yet bone could diminish the transmitted power, which is enough
powerful enough to produce the required gain. Technological to render the device ineffective. The long-term stability of the
advances in recent years have fulfilled these requirements. fixation must also be considered. The mechanical forces acting
at the interface could affect the life expectancy of the device.[6]
Transducer Technology
Candidacy and Selection Criteria[6, 7]
Based on the different transducers used in the design,
current technology offers three types of middle ear implants: Pre-requisites
Piezoelectric, electromagnetic, and electromechanical.[3] • Functioning middle ear without infection
While Dr. Wilska’s work in the 1930s used an electromagnetic • Adults >18 years of age
approach, the first clinically wearable middle ear implants • Bilateral, stable, moderate (hearing loss between 40
were of the piezo-electric type. They are further categorized and 70 dB) to severe (hearing loss between 71 and
as partially or totally implanted. Piezoelectric implants use 90 dB) sensorineural hearing loss as defined by Pure
ceramic structures that are capable of temporary bending if Tone Average with >60% speech discrimination
electric current is applied.[5] When attached to the ossicles, • Realistic expectations of device performance
the implants create vibrations, which can transmit high • Previous experience with hearing aids is recommended.
frequency energy. Due to relative small space of the middle
ear, piezoelectric transducers are likely to be limited in low Indications[6, 8]
frequency output. They have an advantage that they are
compatible with MRI.[3] Electromagnetic implants convert Medical indications: Microtia, aural atresia, exostosis,
electromagnetic signals into ossicular vibrations via a nearby recurrent chronic otitis externa, fire victims, excessive wax
coil without physical contact. A magnet is implanted onto the production, irregular pinna that will not support a hearing
ossicle and vibrates according to the electromagnetic signals aid, allergy to ear mould materialsand previous radical
that are transmitted to the coil from the sound processor. A mastoidectomy. All these patients could be equally benefitted
major limitation of this device is the distance between the from the bone-anchored hearing aids as well.
coil, usually in the external auditory canal, and the magnet.
As the distance increases, the associated output significantly Audiological indications: Noise-induced hearing loss with high
decreases. Electromechanical transducers have the coil and frequency loss and good speech discrimination. Recently,
the magnet in the same assembly and hence the output does soundbridge device has been proposed for use in conductive and
not vary. Piezo-electric hearing aids will only be useful for mixed hearing loss. However, the hearing loss needs to be stable.
someone with a moderate or moderately-severe hearing loss
in the mid and high frequencies. (Maximum output of 110 dB Social indications: Patients requiring a free ear canal for
SPL) The electromagnetic approach can be useful for those with their professions like musicians, swimmers, and physicians.
severe hearing loss. In both the technologies, there is greater
gain and output in the mid-and-high frequency region, than Bone conduction and bone-anchored hearing aids may be used
for lower frequency sounds. Because of regulatory concerns, in conductive and mixed hearing loss. However, their use is
during FDA trials, the electromagnetic MEI manufacturers complicated by the need for accurate placement and sufficient
have limited the output to about 110 dB SPL (similar to the pressure to ensure good coupling between the bone vibrator
piezo-electric MEIs), but theoretically, they should be able to and the skull.[8] Device failures, risk of poor osseo-integration,
transduce up to about 140 dB SPL. and skin reactions have been reported with BAHA.[8] The
superiority of middle ear implants as compared to BAHA in
Clinical Implementation the treatment of conductive hearing loss is still not proven.

Few major biomechanical issues must be addressed in the Contraindications

development of implantable middle ear devices. The first is
that the device should not affect the normal functioning of Chronic otitis media, previous middle ear surgery,
the middle ear. Optimally, it should not alter air-conduction otosclerosis, ossicular erosion, retrocochlear hearing loss,
thresholds. If the device is unsuccessful, the added mass of the tinnitus, and skin diseases in the canal.[6]

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Somayaji G and Rajeshwary A: Middle ear implants: A monogram

Outcomes of the Implant • Medical issues surrounding the middle ear implant surgery
• Surgical risks and side-effects (temporary taste
A middle ear implant does not restore normal hearing and disturbance, tinnitus, dizziness, balance impairment,
requires time to acclimatize to the sound quality. The degree infection, device failure, etc.)
of benefit varies with each individual. Variables influencing • Surgical consent
the benefits each person will derive include factors such as
The device will then be activated about 8 weeks after surgery.
age, degree and duration of hearing loss and integrity of
the auditory system. The advantages of having a middle ear
implant are more natural sound quality, lack of feedback,
General Precautions
absence of occlusion and distortion, and favourable cosmetic
Device working on electromagnetic technology are not MRI-
appearance. Middle ear implants may improve many of
compatible.
the problems associated with hearing aid use, and fully
implantable middle ear implants also allow the patients to
Monoploar surgical instruments are not to be used in the
swim and wash while wearing the device. However, there vicinity of these implants
are some safety issues. Implantation involves a surgical
procedure, which might injure facial nerve, chorda tympani, Diathermy must never be applied over the implant.[3]
and ossicular chain. Some implants may require restriction
to the use of magnetic resonance, electroconvulsive therapy Available Systems
and radiotherapy to the head.[9]
Piezoelectric devices[6]
Patient Management Protocol • Rion device E-type
• Cochlear totally integrated cochlear amplifier
The expected length of assessment from referral to the final • Envoy esteem
consent appointment is typically 18 weeks.
Electromagnetic hearing devices[6]
The initial appointment is meeting with audiologist who will: • Med-El Vibrant sound bridge
• Explain the assessment process • Otologics middle ear transducer and carina
• Take a detailed case history • Soundtec directdrive hearing system
• Discuss the middle ear implant and issues surrounding
implantation, expectationsand potential outcomes Envoy system and the vibrant sound bridge system are
• Conduct basic audiological testing. discussed below.

Suitable patients will subsequently undergo detailed Envoy System

evaluation
• Further clinic appointments will be issued to assess The Envoy is a totally implantable hearing system consisting of
the hearing, amplification needs and functional aided a sensor, a driver and a sound processor. The tip of the sensor
hearing abilities. makes contact with the malleus. As the tympanic membrane
• Hearing aid fitting- to optimize hearing aid setting moves, the vibrations of the ossicular chain are detected by
• Auditory brainstem response test–an objective, non- the sensor, which in turn generates a voltage proportional
invasive hearing test to malleus vibration.[10] The voltage is routed to the sound
• Speech perception tests processor via the sensor lead, where the signal is processed
• Pre-operative questionnaires and amplified.[3] The sound processor sends the information
to the driver, whose tip makes contact with the head of the
The meeting with the ENT surgeon will involve discussion stapes resulting in its vibration.The Esteem envoy system
regarding: uses the eardrum as the microphone, taking advantage of
• Medical history the natural acoustics of the ear canal without obstruction,
• Decisions made regarding further assessments required interference or any external devices. Therefore, the input is
• Magnetic Resonance Imaging (MRI) and possibly identical to that received by a person with normal hearing.[6]
Computer Tomography (CT) may be discussed and
booked to check the integrity of the cochleae and hearing This device is indicated for patients with bilateral non-
nerves. progressive sensorineural hearing loss with atleast 40%

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Somayaji G and Rajeshwary A: Middle ear implants: A monogram

speech reception threshold, who have not been benefitted and crimpled firmly. The long-term effects of an attached
from hearing aids. mass and the pressure created by the crimpled attachment
clip are yet to be assessed.The Vibrant Soundbridge has
The procedure involves cortical mastoidectomy and facial been implanted in many patients worldwide.[11] The device
recess approach.The current battery has a predicted lifetime has now been implanted in some cases for over ten years,
of 5-7 years, depending on use; it can be replaced under local and the long-term results appear favorable. There are no
anaesthesia.Removal of portion of the incus is involved with major complications reported. Minor taste disturbances and
reversibility of the procedure requiring repair of the incus. tinnitus were reported in some studies.[12] Alternate positions
Glue is required to anchor portions of the driver and sensor. for fixing the device are being explored [Figure 2].
The long-term efficacy of this device is yet to be proven[3]
[Figure 1]. Adverse Effects
The Vibrant Soundbridge System Commonly reported adverse events following implantation
include middle ear effusion, tympanic membrane perforation,
The vibrant soundbridge device consists of an external ossicular discontinuity, hematoma of the ear canal and
audio processor and an electromagnetic system referred tympanic membrane, impairment of taste and ear pain. In
to as the vibrating ossicular prosthesis(VORP). The VORP the studies reporting adverse events, device malfunction
contains a receiver, conductor link and the floating mass occurred in 5.7% of the patients.[9]
transducer (FMT). The FMT consists of two energizing coils
wrapped around hermetically sealed titanium housing with Conclusion
a magnet inside. Sound picked up by the audio processor is
The utility of middle ear implants is only beginning to
processed, amplifiedand sent via radiofrequency signals to
be appreciated. As additional information accumulates,
the VORP. The VORP receives the signal and transmits the
the medical and rehabilitative fields will continue to
information to the FMT that, via an electromagnetic field,
gain experience with the effectiveness of current device
directly vibrates the ossicular chain. The surgery performed
technologies and witness the continued advancement of
is called vibroplasty, which means vibratory stimulation of
this technology towards the treatment of hearing loss.
the ossicles in the middle ear. It could be a round window
Preliminary reports indicate that the technology is safe
vibroplasty or TORP/PORP vibroplasty.
and effective for those adults seeking as alternate means
of amplification. Binaural amplification is advantageous.
The patient needs to have normal middle ear, stable hearing
Studies are being done on the advantages of fully implantable
loss with no improvement from conventional hearing aids. The
systems, which could greatly enhance the quality of life,
procedure involves a cortical mastoidectomy and a posterior
bringing all the benefits of performance, comfortand
tympanotomy and is similar to the cochlear implantation.[11] It
convenience to patients.[3]
does not involve disarticulation of the ossicular chain.[3] FMT
should be positioned as superiorly as possible on the incus
Future Research
Figure 1: The Envoy system: a: Implant with sensor and actuator.
b: Positioning of the implant. The possibility of hydroacoustic transmission via a water-
filled tube either to the ossicles or directly to the round

Figure 2: The vibrant soundbridge system. a: Connection to long

process of incus; b: Connection to round window. c: Laterally on a bell
prosthesis; d: Linearly as TORP vibroplasty; e: Next to a stapes piston.
a
b c

b a d e

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Somayaji G and Rajeshwary A: Middle ear implants: A monogram

window membrane has been under investigation.[13] Clinical 7. Soundtec direct system. FDA summary of safety and
trials of round window stimulation using the vibrant effectiveness. Available from: http://www.accessdata.fda.gov/
cdrh_docs/pdf/P010023b.pdf. [Last accessed on Sept 2013].
soundbridge are currently underway. Research is being 8. Boheim K. Active middle ear implants. Adv Otolaryngol
done in developing MRI compatible totally implatable Basel Karger2010;69:38-50.
devices. 9. Butker CL,Thavaneswaran P,Lee IH. Efficacy of the active
middle ear implant in patients with sensorineural hearing
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