Implantable Hearing Devices other than Cochlear Implants

Visit the link below to download the full version of this book:

https://medipdf.com/product/implantable-hearing-devices-other-than-cochlear-impl
ants/

Click Download Now

Editor
Gauri Mankekar, MS, DNB, PhD
ENT
PD Hinduja Hospital
Mumbai
India

ISBN 978-81-322-1909-5 ISBN 978-81-322-1910-1 (eBook)

DOI 10.1007/978-81-322-1910-1
Springer New Delhi Heidelberg New York Dordrecht London

Library of Congress Control Number: 2014946620

© Springer India 2014

This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of
the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation,
broadcasting, reproduction on microfilms or in any other physical way, and transmission or information
storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology
now known or hereafter developed. Exempted from this legal reservation are brief excerpts in connection
with reviews or scholarly analysis or material supplied specifically for the purpose of being entered and
executed on a computer system, for exclusive use by the purchaser of the work. Duplication of this
publication or parts thereof is permitted only under the provisions of the Copyright Law of the Publisher's
location, in its current version, and permission for use must always be obtained from Springer.
Permissions for use may be obtained through RightsLink at the Copyright Clearance Center. Violations
are liable to prosecution under the respective Copyright Law.
The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication
does not imply, even in the absence of a specific statement, that such names are exempt from the relevant
protective laws and regulations and therefore free for general use.
While the advice and information in this book are believed to be true and accurate at the date of
publication, neither the authors nor the editors nor the publisher can accept any legal responsibility for
any errors or omissions that may be made. The publisher makes no warranty, express or implied, with
respect to the material contained herein.

Printed on acid-free paper

Springer is part of Springer Science+Business Media (www.springer.com)

Foreword

Modern otologic implants are a far cry from the original vinyl acrylic ossicular
prostheses first introduced in the early 1950s. The field of otology is rapidly evolv-
ing and today more than ever, staying well informed on the breadth of available
implantable hearing devices presents a significant challenge for the busy ear sur-
geon. Dr. Mankekar was able to secure an exceptional cast of world-renowned lead-
ers in the field to provide subspecialty expertise on passive alloplastic ossicular
prostheses, implantable bone conduction devices, and active middle ear implants.
Implantable Hearing Devices other than Cochlear Implants was carefully
designed to provide a practical, comprehensive reference covering prosthesis devel-
opment, candidacy evaluation, surgical implantation, adverse events and clinical
outcomes. Most otolaryngology texts have limited the discussion of otologic
implants to one or two chapters; never before has such a comprehensive book been
published on the subject. It is a distinct pleasure and honor to present the first edi-
tion of Dr. Mankekar’s work. There is no question that this book will prove to be an
invaluable resource for otologists and general otolaryngologists alike.

Rochester, MN, USA Matthew L. Carlson, MD

Nashville, TN, USA Michael E. Glasscock III, MD

v
Preface

In his autobiography No More Laughing at the Deaf Boy, Geoffrey Ball writes
“although my hearing aids made everything louder, they did not make anything
clearer” [1].
This has been the experience of millions of hearing aid users around the world.
Conventional hearing aids have served to amplify residual hearing and provide
hearing rehabilitation. Despite technological advances, conventional hearing
aids still have many limitations. They amplify all sounds and not only speech
sounds. This makes it difficult for the wearer to understand speech clearly.
Hearing aids require frequent battery changes, have to be worn with customized
moulds. In tropical countries, digital hearing aids require frequent dehumidifica-
tion. Some patients are unable to tolerate them either due to blocking of their
external ear canal [2] or due to problems with hearing in noise and poor sound
quality. The functional gain of the hearing aids can be limited by annoying feed-
back due to faulty ear moulds or faulty circuitry or external canal issues. Hearing
aids cannot be used regularly by those with chronically discharging ears, otitis
externa or mastoid cavity issues or exostoses or frequent wax impaction. Also
fitting conventional hearing aids does not provide a solution for everyone [3]. In
addition to all this, even today, hearing aids are associated with the stigma of
“old age” and most patients with hearing impairment try to postpone being fitted
with them.
Over the past several decades, researchers, otologists and biomedical engineers
have been trying to develop hearing devices to overcome the drawbacks of hearing
aids and provide near natural sound quality to hearing impaired patients. These
hearing devices can today treat conductive, mixed and sensorineural hearing losses
and can be categorized as active (bone conduction devices, implantable middle ear
prostheses, cochlear implants and auditory brainstem implants) and passive
implants. Some of these devices are partially implantable while some are fully
implantable. Each of these devices has specific indications and patients have to
undergo several investigations before being confirmed as candidates for these
devices.
Implantable hearing devices can be classified as active or passive. Active middle
ear implants depend upon an external source of energy for their functioning [4].

vii
viii Preface

Passive middle ear implants include the total and partial ossicular replacement pros-
thesis and the stapes prosthesis used for ossicular reconstruction in chronic ear dis-
ease or otosclerosis. Active middle ear implants are electronic devices which are
surgically implanted to correct hearing loss by stimulating the ossicular chain or the
middle ear [5]. Since these implants are placed into the middle ear, they do not
obstruct the external auditory canal. The implant itself usually consists of a micro-
phone, an audio processor, a battery, a receptor and a vibration transducer which
attaches to the ossicular chain [5]. The transducer could be either piezoelectric or
electromagnetic and produces vibrational energy that subsequently vibrates the
ossicular chain [6]. The attachment of the transducer to the ossicular chain should
be secure otherwise the device will separate resulting in device failure [7]. The
device is attached either by creating an opening in the incus and using an adhesive
or crimping the device to the incus; or disarticulation and placement of the device at
the incudostapedial joint [7].
Active middle ear implants may remove many issues relating to hearing aid
use such as sound distortion, ear canal occlusion (particularly relevant for
patients with chronic otitis externa and media), acoustic feedback, autophony,
inadequate amplification, discomfort and social stigma [5, 7, 8]. Some fully
implantable devices also allow patients to swim and bathe while wearing the
device [9].
On the other hand, there may be potential hazards associated with active middle
ear implants: the implants have to be placed surgically usually under general anes-
thesia. Failure of the device will necessitate another surgery for explantation and
re-implantation. There is an intra-operative risk of injury to the chorda tympani
nerve leading to dysgeusia or injury to the facial nerve leading to facial palsy [10].
Noise of drilling and suction during surgery can cause decline in cochlear function
[11]. Mass loading of the ossicular chain may lead to residual hearing loss, the
extent of which is directly related to the weight of the middle ear implant and to the
location of its placement in the middle ear [12, 13]. Further, there is a potential risk
of damage to the ossicular chain, and the use of magnetic resonance imaging, elec-
troconvulsive therapy and radiotherapy of the head may be restricted with some
devices [5].
Much has been written about cochlear implants and auditory brain stem implants.
So this book will attempt to dwell on passive implants and the other currently mar-
keted active implants namely Bone Conduction Implants, Vibrant Soundbridge,
Esteem and Maxum.
The chapter on passive implants discusses the importance of Eustachian tube
function, role of a healthy middle ear mucosa and biofilms in the acceptance of
the various middle ear prosthesis. Bone conduction devices, Vibrant Soundbridge,
Maxum and Esteem Implants can help those who cannot be provided with hear-
ing rehabilitation with either conventional hearing aids or passive middle ear
implants.

Mumbai, India Gauri Mankekar, MS, DNB, PhD (Germany)

Preface ix

Table 1 Types of hearing losses and available options for hearing rehabilitation (Each option has
its own specific indication)
Type of hearing loss Available options
Conductive hearing loss 1. Surgery with or without middle ear prosthesis
2. Conventional hearing aids
3. Bone conduction implant devices
Sensorineural hearing loss 1. Conventional hearing aids
2. Maxum/Esteem
3. Cochlear implants
4. Auditory brain stem implants
Mixed hearing loss 1. Conventional hearing aids
2. Vibrant soundbridge
3. Bone conduction devices
Passive Middle Ear Implants.-Implantable Hearing Devices Besides Cochlear and Brain Stem
Implants.-Bone Conduction Implant Devices.-Middle Ear Implants (MEI): Vibrant Soundbridge.-
The Envoy Esteem® Hearing Implant.-The Ototronix MAXUM System

References
1. Ball G. No more laughing at the deaf boy. Innsbruck Wien: Haymon Verlag, 2011.
2. Kochkin S, MarkeTrak V. Why my hearing aids are in the drawer: the consumer’s perspective.
Hear J. 2000;53:34–42.
3. Stokroos RJ1, George EL. Hearing implants. Ned Tijdschr Geneeskd. 2013;157(51): A6927.
4. Zenner HP. Implantierbare Hörgeräte – aktueller Stand. In: Jahnke K, editor. Middle ear sur-
gery. Stuttgart: Thieme; 2000. p. 141–61.
5. Manrique M, Valdivieso A, et al.. Review of audiometric criteria in treatment of neurosensorial
deafness with hearing aids and implantable hearing devices. Acta Otorrinolaringologica
Espanola. 2008;59:30–8.
6. Kulkarni K and Hartley DEH. Recent advances in hearing restoration. J R Soc Med.
2008;101:116–24.
7. Shinners MJ, Hilton CW, Levine SC. Implantable hearing devices. Curr Opin Otolaryngol
Head Neck Surg. 2008:16:416–19.
8. Chang P. Implantable hearing devices: beyond hearing aids. Aust Fam Physician. 2005;34:157–61
9. Backous DD, Duke W. Implantable middle ear hearing devices: current state of technology and
market challenges. Curr Opin Otolaryngol Head Neck Surg. 2006;14:314–8.
10. Lloyd S, Meerton L, et al. Taste change following cochlear implantation’, Cochlear Implants
International, 2007;8:203–10.
11. Snik AFM, Cremers CWRJ. The effect of the “floating mass transducer” in the middle ear on
hearing sensitivity. Am J Otol. 2000;21:42–8.
12. Hough JVD, Dyer RK, et al. Early clinical results: SOUNDTEC implantable hearing device
phase II study’, The Laryngoscope, 2001;111:1–8.
13. Vincent C, Fraysse B, et al. A longitudinal study on postoperative hearing thresholds with the
Vibrant Soundbridge device. Eur Arch Otorhinolaryngol. 2004;261:492–6.
Acknowledgements

The publication of this book has been possible due to Springer and the hard work of
all the authors. I would like to thank Prof. Glasscock who enthusiastically agreed to
author two chapters and write the foreword when I discussed the idea of this book.
A big thank you to Matt Carlson, who not only co-authored the foreword and the
chapters with Prof. Glasscock, Dr. Alex Sweeney and Dr. Stanley Pelosi but also
co-ordinated the submissions; Prof. Dr. med. Konrad Schwager, an excellent otolo-
gist with a special interest in passive implants, for agreeing to write the chapter on
passive implants despite his extremely busy schedule; and Prof. Mario Emilio
Zernotti, who at the onset suggested ideas for this book and then wrote the chapter
on the Vibrant Soundbridge.
I would like to thank my teachers Dr. Ingle, Dr. Kirtane, Dr. Pusalkar, Prof. Jan
Helms, Prof. Steinbach and Prof. Hildmann for training me in otology.
A big thank you to Dr. Eti Dinesh, Ms. Teena Bedi and everyone at Springer, for
their efforts in publishing this book.

xi
Contents

1 Passive Middle Ear Implants. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Konrad Schwager
2 Implantable Hearing Devices Besides Cochlear
and Brain Stem Implants. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Gauri Mankekar
3 Bone Conduction Implant Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Gauri Mankekar
4 Middle Ear Implants (MEI): Vibrant Soundbridge . . . . . . . . . . . . . . . 71
Mario Emilio Zernotti and Peter Grasso
5 The Envoy Esteem® Hearing Implant. . . . . . . . . . . . . . . . . . . . . . . . . . . 85
Alex D. Sweeney, Matthew L. Carlson,
and Michael E. Glasscock III
6 The Ototronix MAXUM System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
Stanley Pelosi, Matthew L. Carlson, and Michael E. Glasscock III

xiii
Passive Middle Ear Implants
1
Konrad Schwager

Introduction, Historical Remarks

Passive middle ear implants, by definition, reconstruct the disrupted or fixed ossicu-
lar chain. A prerequisite for an optimal sound transmission system is an aerated
middle ear space and a closed tympanic membrane, both of which are passive con-
ditions, and a normal functioning inner ear as the active part of the system.
Knowledge of the natural environment in the middle ear space and the acoustic
and mechanical properties of the sound transmitting apparatus (tympanic mem-
brane, ossicular chain) is a prerequisite to the understanding of ossicular reconstruc-
tion. The main focus is on the surface conditions for implantation materials,
followed by questions regarding design and mechanics. It is obvious that a strong
differentiation of these features is not always possible. Some of the newer implants
consist of composites and material mixes, with new surface and acoustic properties.
Thus some redundancy and overlap in presentation is unavoidable.
From the beginning, the treatment of middle ear disease had two aims. One was
the eradication of chronic middle ear inflammation and the second was the resto-
ration of hearing. Otosclerosis, a noninfectious condition of the middle ear with
ankylosis of the stapes as the main symptom, is a separate entity and has to be
discussed separately. But in both, otosclerosis and chronic middle ear disease, there
is the need for ossicular reconstruction depending on whether the ossicles are fixed
by ankylosis or destroyed by the infective process. The needs for new materials
increased at the beginning of modern reconstructive middle ear surgery in the early
1950s. The pioneers were Moritz, Wullstein, and Zöllner. In 1952, Wullstein started
using Palavit® (vinyl-acrylic resin) [1] as a material for total ossicular replace-
ment prostheses. The clinical results were not encouraging, and the material was

K. Schwager
Department of ENT, Head and Neck Surgery, Klinikum Fulda, Fulda, Germany
e-mail: [email protected]

© Springer India 2014 1

G. Mankekar (ed.), Implantable Hearing Devices other than Cochlear Implants,
DOI 10.1007/978-81-322-1910-1_1
2 K. Schwager

abandoned after a short period of time because of high extrusion rates. There was a
long learning curve to understand the requirements necessary to meet acceptance in
the middle ear and to have adequate sound transmission properties. Surgeons usu-
ally present audiological results to demonstrate the success or failure of these pros-
theses. The surface properties therefore have been underestimated in this context for
a long time. But they are probably the most important factor in ossiculoplasty [2].

Middle Ear Space: A Unique Implantation Site

The requirements for a material in ossicular replacement are multifold. The material
should be nontoxic, it should not alter connecting proteins, it should behave like
tissue towards tissue, and there are acoustic properties that are necessary for sound
conduction [3, 4].
An implantation site may be open, semi-open, or closed [5]. A typical closed situa-
tion would be the bone or any other tissue in the body with no connection to the outside
environment. An open implantation site is typically an implant that penetrates the skin
or mucosa like in a bone-anchored hearing aid or in a dental implant. The situation in the
middle ear is unique [6]. In the normal healthy state, the middle ear is a well-defined,
good aerated cave, free of any infectious agent. But the connection via the Eustachian
tube towards the external environment makes it semi-open. During upper airway infec-
tion and especially during acute otitis media, it is potentially colonized by viruses and
bacteria. In such an environment and under such conditions, biomaterials require a
higher and different quality of surface properties than in closed implantation [3–5, 7, 8].
Audiological and sound transmission properties are fulfilled by many materials, both
biological and artificial. But the characteristics of the described surroundings are a cru-
cial factor for the long-term success of a middle ear implant. Most of these questions
were poorly understood in earlier times compared to nowadays. More recently, biofilms
are considered to play a significant role in foreign material acceptance [9]. Biofilms
result when microbes colonize implants. Aqueous and moist surfaces are covered with
a thin layer of mucous film, able to host microorganisms. The unique surrounding in the
middle ear provides all these requirements. Pseudomonas aeruginosa is regularly cul-
tured in chronic suppurative otitis media with and without cholesteatoma. This microor-
ganism is known to form biofilms on implantation materials [10, 11]. Prostheses made
of titanium, hydroxyapatite, and Polycel have been studied, cultured with Pseudomonas
aeruginosa. In the results, titanium prostheses formed less biofilms than plastic and
hydroxyapatite. To understand these complex situations of the implantation site, besides
in vitro studies, animal experiments are also necessary to be performed [12, 13].

Middle Ear Mucosa and Eustachian Tube (ET) Function

Normal middle ear function is based on balanced middle ear aeration. This is a
result of a complex system involving at least these two major contributors: the mid-
dle ear mucosa and the Eustachian tube [14]. Both aspects seem to be the most
important part of the system of a functioning middle ear. Proper diagnoses of severe
1 Passive Middle Ear Implants 3

aeration problems and tubal dysfunction are difficult because the system, its parts,
and their complex interaction are not fully understood. Treatment possibilities of
either part of the system are low. The contribution that has been approached in the
past by various modalities is the Eustachian tube [15].
More recently, Eustachian tube (ET) dilatation has come into focus in treating middle
ear aeration problems. Compared to other therapeutic modalities, the results with dilata-
tion are encouraging to date. “Balloon Eustachian tuboplasty” has been introduced by
two different groups: the Bielefeld group [16] and the Boston group [17]. Due to the
dilation procedure, micro-fractures of the tubal cartilage with a successive expansion of
the Rüdinger’s safety canal could be experimentally observed. But the in vivo mecha-
nism of the therapy is still unclear. Sudhoff and colleagues [18] treated 351 patients, of
which the short-term results of 167 patients 2 months after the treatment and the long-
term results of 53 patients 1 year after the treatment were recently published. According
to their results, this procedure was satisfactory for 87 % of their patients. The Eustachian
tube function tests were significantly better in more than 90 % of the cases. From this
data, it seems that ET dilation may have a positive influence.
Classical tympanoplasty techniques resolve mechanical problems, such as due to
the disrupted and fixed ossicular chain and perforated eardrums, but has little effect
on tubal dysfunction. There has been a trend toward surgical procedures that pre-
serve the mucosa of the mastoid and antrum, with the concept that disruption of the
mucosa is as counterproductive in temporal bone surgery as it is in sinus surgery.
Thus, the surgical principle when treating chronic middle ear disease is to support
mucosal healing while restoring a closed middle ear space. Real options for the
treatment of the mucosal disease are still missing.

Basic Considerations in Tympanoplasty and Ossiculoplasty

The first aim of treatment in chronic middle ear disease is still to cure the chronic
inflammation. The risk of complications will depend on the entity of the middle ear
disease. The most dangerous disease regarding infectious complications is undoubt-
edly cholesteatoma. Otogenic facial paresis, intracranial complications (sinus
thrombosis, meningitis, epidural, subdural and brain abscess), and labyrinthitis are
more often associated with cholesteatoma than with other entities of chronic ear
disease. In the case of chronic suppurative otitis media, a runny ear may be seen as
a less dramatic situation, and the risk of life-threatening complications negligible,
but the hearing loss will slowly increase. It starts with a pure conductive loss that
can be treated by tympanoplasty and ossiculoplasty techniques, but over time, it will
develop a sensorineural component due to toxic inflammatory influences.

Materials for Reconstruction of the Tympanic Membrane

Many materials have been suggested for tympanic membrane reconstruction. Three
tissues of autogenic origin are used today: temporalis fascia (likely the material
most favored by surgeons all over the globe), perichondrium, and cartilage [19].