sonatatI - Med-El
sonatatI - Med-El
sonatatI - Med-El
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<strong>sonatatI</strong><br />
Cochlea-Implantat<br />
100<br />
CoChlear Implant of the<br />
maestro CI system
2<br />
this is a<br />
Contents<br />
The Latest Cochlear Implant Technology ........................................................3<br />
New Generation I 100 <strong>El</strong>ectronics ............................................................................4<br />
:: 100% on-Chip Design ........................................................................................5<br />
:: precision stimulation ............................................................................................5<br />
:: power efficient ........................................................................................................5<br />
Safe & Reliable Implant Design ...............................................................................6<br />
:: proven reliability .................................................................................................7<br />
:: IrIs Implant Identification ...............................................................................7<br />
:: mrI Compatibility .................................................................................................7<br />
In Tune with the Future .............................................................................................8<br />
:: finehearing ..........................................................................................................9<br />
:: Complete Cochlear Coverage ......................................................................10<br />
<strong>El</strong>ectrode Options .......................................................................................................12<br />
Comprehensive Diagnostic Toolkit ....................................................................14<br />
Raquel, Italy... .................................................................................................................15<br />
SONATATI 100 Technical Specifications ...............................................................17<br />
MED-EL – A Visionary Company ........................................................................18<br />
the <strong>sonatatI</strong> 100 features meD-el’s<br />
advanced I 100 electronics in a an<br />
exceptionally compact titanium housing
the latest<br />
Cochlear Implant<br />
technology<br />
the <strong>sonatatI</strong> 100 cochlear implant is engineered for<br />
unparalleled precision and performance. It com bines<br />
an exceptionally small-volume and thin titanium<br />
housing with meD-el’s powerful next generation<br />
I 100 electronics.<br />
the <strong>sonatatI</strong> 100 supports advanced developments<br />
offering implant users greater sound detail and<br />
clarity – particularly beneficial for music enjoyment<br />
and difficult listening situations.<br />
In line with the meD-el product development<br />
philosophy, the <strong>sonatatI</strong> 100 is designed for forward<br />
compatibility, the inbuilt capacity for implementing<br />
future upgrades and enhancements.<br />
3
4<br />
new Generation<br />
I 100 electronics<br />
meD-el’s highly advanced I 100 electronics platform<br />
pro vides implant users access to the fastest and<br />
most effective speech coding strategies available<br />
today. the electronics platform supports finehearing <br />
and Complete Cochlear Coverage, the latest<br />
developments designed for greater sound detail and<br />
clarity. see p. 8 for more details.<br />
next generation I 100 electronics for unprecedented<br />
sound detail and clarity
100% on-Chip Design<br />
<strong>sonatatI</strong> 100 Cochlear Implant<br />
the electronic components of the <strong>sonatatI</strong> 100 are arranged on a single<br />
custom-designed asIC (application specific Integrated Circuit) microchip.<br />
the efficicient microchip processes large amounts of sound data while<br />
keeping the energy requirements to a minimum.<br />
precision stimulation<br />
<strong>sonatatI</strong> 100 has 24 independent current sources for highly precise, highrate<br />
stimulation over the entire length of the cochlea. research shows that<br />
an optimal implant speed causes the auditory nerve to behave similarly to<br />
natural hearing. <strong>sonatatI</strong> 100 mimics natural hearing by stimulating at rates<br />
matching the abilities of the recipient’s auditory nerve.<br />
power efficient<br />
each hair-thin platinum wire is insulated with ruby<br />
crystals for highly precise transfer of stimulation<br />
pulses to the electrode contacts<br />
meD-el’s patented power-efficient technology makes it possible to provide<br />
recipients with the benefits of high-rate stimulation and the comfort of an<br />
especially small behind-the-ear (Bte) audio processor. this energy efficiency<br />
also translates into long battery life, typically 3–5 days of use per set of<br />
batteries.<br />
5
6<br />
safe & reliable<br />
Implant Design<br />
like every device in meD-el’s maestro cochlear<br />
implant system, the <strong>sonatatI</strong> 100 is designed<br />
according to the highest safety standards for<br />
long-term reliability, durability and performance.<br />
extensive research and development, the highest<br />
quality materials, rigorous testing procedures and<br />
continuous analysis of the data obtained from users<br />
and professionals ensure that users of meD-el<br />
hearing implants receive safe and effective<br />
medical devices.
proven reliability<br />
the <strong>sonatatI</strong> 100 features a compact, lightweight<br />
package, combining robust titanium and flexible<br />
silicone. Its exceptionally small size and thinness<br />
makes it ideal for infants and toddlers as well as<br />
adults, and is also designed to allow minimally<br />
invasive surgical techniques and faster recovery.<br />
Data show outstanding reliability with the<br />
<strong>sonatatI</strong> 100 . please find current reliability data<br />
(Cumulative survival rate, Csr) at www.medel.com.<br />
IrIs Implant Identification<br />
<strong>sonatatI</strong> 100 Cochlear Implant<br />
meD-el’s unique implant identification feature, IrIs (Individual<br />
recognition of the Implant system), prevents stimulation from occurring<br />
if the incorrect audio processor is worn. this is particularly important for<br />
children with bilateral implants and for school and group situations where<br />
numerous children may be using implants.<br />
mrI Compatibility<br />
some cochlear implant users will require an mrI (magnetic resonance<br />
Imaging) scan at some point in their lifetime, so mrI compatibility is an<br />
important consideration when selecting a cochlear implant. meD-el offers<br />
mrI compatibility without surgical removal of the implant magnet. 1 at meD-el,<br />
we recognise the importance of providing access to critical medical treatment,<br />
including mrI, without disruption to your life or your hearing.<br />
SONATATI 100 is MRI compatible1 at 0.2, 1.0 and 1.5 Tesla<br />
:: no need for surgery<br />
:: no negative impact on hearing during recovery<br />
:: no additional risk to the patient<br />
1 Contact meD-el prior to mrI examination for important guidelines.<br />
7
8<br />
In tune<br />
with the future<br />
for decades, the greatest challenges in cochlear<br />
im plant performance have included music enjoyment<br />
and speech understanding in noise. the<br />
sophisticated I 100 electronics platform of the<br />
<strong>sonatatI</strong> 100 supports finehearing and Complete<br />
Cochlear Coverage, technologies designed to<br />
provide greater sound detail and clarity in listening<br />
situations.<br />
these unique meD-el innovations make it possible<br />
to enhance music enjoyment and improve speech<br />
understanding in difficult listening situations.
finehearing <br />
<strong>sonatatI</strong> 100 Cochlear Implant<br />
sound processing determines how sounds (music, speech, environmental<br />
sounds, etc.) are converted by the audio processor into electrical pulses<br />
that stimulate the cochlea. the opUs 2 supports a wide variety of sound<br />
processing strategies, including fine structure processing, to ensure the best<br />
possible performance.<br />
Life – It‘s in the Detail<br />
finehearing technology was developed to provide cochlear implant users<br />
with the fine details of sound for a richer, more detailed hearing experience.<br />
these details, known as fine structure, contain cues that are especially<br />
important when listening to music or having conversations in noisy<br />
environments.<br />
envelope<br />
fine structure<br />
In simplified terms, a sound signal can be separated into two parts: the<br />
envelope and the fine structure. the envelope is a general outline of a<br />
sound signal that reflects changes in loudness (amplitude) over time. the<br />
fine structure contains more detailed information and reflects the rapidly<br />
changing pitch (frequency) details.<br />
Until now, cochlear implant systems have been able to transmit envelope<br />
information only. for the first time, meD-el’s finehearing technology allows<br />
users to benefit from the subtle details of sound.<br />
a visual representation of the details<br />
provided by finehearing <br />
envelope<br />
envelope and<br />
fine structure<br />
9
10<br />
Complete Cochlear Coverage<br />
hand in hand with finehearing , meD-el’s unique Complete<br />
Cochlear Coverage (CCC) provides users with outstanding<br />
pitch perception in the lower frequencies. the particularly long<br />
electrode stimulates more nerve fibres allowing the fine details<br />
of sound to be heard. this offers an unsurpassed hearing<br />
experience closer to natural hearing.<br />
Complete Cochlear Coverage means stimulating the entire<br />
frequency range of the cochlear from the base to the apical<br />
region (uppermost part) in order to closely mimic natural<br />
hearing. meD-el manufactures the longest electrode arrays<br />
currently available, extending 31.7 mm (1.25 in) in order<br />
to stimulate the maximum number of nerve fibres. most<br />
importantly, this includes the low frequencies, which could not<br />
otherwise be stimulated using electrodes that do not reach<br />
into the apical region.<br />
Frequency<br />
4000 Hz 250 1000 Hz<br />
Hz<br />
Apical Region<br />
500 Hz<br />
8000 Hz<br />
Basal Region<br />
Low Pitch 500 Hz<br />
High Pitch
<strong>sonatatI</strong> 100 Cochlear Implant<br />
11
12<br />
electrode options<br />
meD-el leads the cochlear implant industry in pro viding<br />
soft and flexible electrode arrays for Complete Cochlear<br />
Coverage (CCC) with maximum protection of the<br />
delicate inner ear structures. only Complete Cochlear<br />
Coverage of the electrode gua ran tees the stimulation<br />
of the highest possible number of nerve fibres in the<br />
cochlea. With CCC, the user can perceive a broader<br />
frequency range and the experience of sound becomes<br />
richer and more natural.<br />
Different electrode options guarantee an optimal solution<br />
for each patient even in difficult situations such as an<br />
ossified cochlea or for individuals with re si dual hearing.<br />
meD-el deep insertion electrodes allow all areas of the cochlea to be<br />
stimulated. X-ray microsocopy by prof. hüttenbrink.<br />
standard electrode array<br />
the standard electrode array offers the deepest insertion<br />
(31.7 mm/1.25 in) and widest contact spacing (2.4 mm / 0.09 in)<br />
available today. It features 12 pairs of electrode contacts and is<br />
designed to provide stimulation of the entire cochlear from base<br />
to apex.
medium electrode array<br />
<strong>sonatatI</strong> 100 Cochlear Implant<br />
the medium electrode array features 12 electrode pairs with<br />
moderate contact spacing for cases where deep insertion is not<br />
desired or is not possible due to anatomic restrictions.<br />
Compressed electrode array<br />
specifically designed for partial ossification or malformation of<br />
the cochlea, the Compressed electrode array features 12 pairs of<br />
contacts equally spaced over a shorter distance to maximise the<br />
number of channels available and optimise performance.<br />
fleX soft electrode array<br />
similar to the standard electrode array, the fleX soft electrode<br />
array allows deep insertion into the apical region of the cochlea.<br />
the specially designed leading section offers increased mechanical<br />
flexibility for reduced insertion force.<br />
fleX eas electrode array<br />
the fleX eas electrode array is intended for situations in which<br />
insertion no deeper than the basal cochlear turn is desired. the<br />
array features a specifically designed leading section with increased<br />
mechanical flexibility and reduced insertion force.<br />
for additional information on electrode arrays, contact your local CI centre or meD-el office.<br />
13
14<br />
Comprehensive<br />
Diagnostic toolkit<br />
the <strong>sonatatI</strong> 100 is designed to support a wide range of telemetry and<br />
assessment functions, enabling professionals to test implant function<br />
precisely and to monitor the interaction between the implant and the<br />
auditory nerve<br />
the Comprehensive Diagnostic toolkit (CDt) is a set of advanced<br />
diagnostic tools for use by cochlear implant professionals. CDt employs<br />
innovative techniques, including triphasic precision pulses and adaptive<br />
sigma-Delta modulation, to obtain highly precise information from the<br />
implant.<br />
:: Impedance & Field Telemetry (IFT) – information on the implant and<br />
electrode function.<br />
:: Status Telemetry – information on the unique implant ID and certain<br />
stimulation parameters<br />
:: Auditory Nerve Response Telemetry (ART ) – precise information on<br />
the physiological response of the auditory nerve to stimulation through<br />
the cochlear implant. art employs adaptive sigma-Delta modulation<br />
operating at 1.2 megasamples per second. this results in higher resolution<br />
of the nerve response, reduced artifacts and better eap predictability.<br />
Signal µV<br />
0 500 1000<br />
N<br />
N<br />
N<br />
0 500<br />
P<br />
P<br />
P<br />
1000 1500<br />
Time µs<br />
Amp. = 800 cu<br />
Amp. = 700 cu<br />
Amp. = 600 cu<br />
Amp. = 500 cu<br />
Amp. = 400 cu<br />
Amp. = 300 cu<br />
an example of an art recording with variations in stimulation current.
aquel, Italy<br />
“after she got her second implant,<br />
she was so proud, she told<br />
everyone that now she had two.<br />
she was just so proud.”<br />
paola, raquel’s mum<br />
<strong>sonatatI</strong> 100 Cochlear Implant<br />
15
16<br />
<strong>sonatatI</strong> 100 Cochlear Implant
<strong>sonatatI</strong> 100<br />
technical specifications<br />
Mechanical Design<br />
Stimulator Housing<br />
length: 17.4 mm *<br />
Width: 24,8 mm *<br />
thickness: 5.9 mm<br />
Overall Implant Dimensions<br />
length: 45.7 mm<br />
Width at coil: 29.0 mm<br />
Width at stimulator: 24.8 mm<br />
thickness at coil: 3.7 mm<br />
thickness at stimulator: 5.9 mm<br />
Weight: 8.6 g<br />
Standard <strong>El</strong>ectrode Array<br />
Contact configuration<br />
24 electrodes arranged as 12 twin-surfaces<br />
Geometric surface per channel: 0.14 mm 2*<br />
Dimensions<br />
Distance between electrodes: 2.4 mm *<br />
electrode diameter at apical end: 0.5 mm *<br />
electrode diameter at basal end: 1.3 mm *<br />
1 100 <strong>El</strong>ectronics<br />
3.7 mm<br />
5.9 mm<br />
Pulse Shapes<br />
Biphasic, symmetric triphasic and triphasic precision pulses<br />
Stimulation Features<br />
sequential and parallel stimulation<br />
maximum pulse rate: 50.704 pulses per second<br />
pulse width per phase: 2.08–425.0 μs/ph<br />
time resolution (nominal values): 1.67 μs<br />
overall amplitude range: 0–1200 cu *<br />
Comprehensive Diagnostic Toolkit<br />
Impedance and field telemetry (Ift)<br />
status telemetry<br />
auditory nerve response telemetry (art )<br />
135.5 mm<br />
31.7 mm<br />
24.8 mm<br />
28.3 mm<br />
17.4 mm<br />
* typcial value<br />
17
1977 Implantation<br />
of the world’s first<br />
hybrid multi-channel<br />
cochlear implant in<br />
Vienna.<br />
1975 Cochlear<br />
implant development<br />
started by meD-el<br />
founders Ingeborg<br />
and erwin hochmair.<br />
18<br />
meD-el<br />
a Visionary Company<br />
since meD-el’s founders developed one of the world’s first cochlear<br />
implants in 1975, a strong research tradition has continued to fuel the<br />
development of technologically advanced hearing solutions. meD-el<br />
offers implantable solutions to treat different degrees of hearing loss,<br />
including cochlear and middle ear implants, combined electric acoustic<br />
stimulation and auditory brainstem implants.<br />
1990 meD-el hires<br />
its first employees.<br />
1989 Introduction<br />
of the Comfort<br />
cochlear implant.<br />
1994 Introduction<br />
of the ComBI 40,<br />
the world’s first<br />
multi-channel highrate<br />
cochlear implant.<br />
1991 meD-el<br />
launches the world’s<br />
first BTE (behindthe-ear)<br />
speech<br />
processor.<br />
1996 Introduction<br />
of the ComBI 40+,<br />
the thinnest cochlear<br />
implant available.<br />
1995 Introduction<br />
of the CIs lInK<br />
system.<br />
1997 the ComBI<br />
40+ split electrode<br />
(GB) is introduced<br />
for cases of cochlear<br />
ossification.
2003 acquisition<br />
of the Vibrant<br />
soundbridge ® , the<br />
first implantable<br />
middle ear hearing<br />
device for mild-tosevere<br />
sensorineural<br />
hearing loss.<br />
1999 launch of the<br />
tempo+ behindthe-ear<br />
(Bte) speech<br />
processor.<br />
2004 meD-el<br />
launches the<br />
pUlsarCI 100 cochlear<br />
implant, providing<br />
future-ready<br />
electronics in a<br />
ceramic housing.<br />
2007 approval of<br />
eas, the ideal solution<br />
for partial deafness,<br />
and the Vibrant<br />
soundbridge ® for<br />
conductive and mixed<br />
hearing losses in<br />
europe. launch of the<br />
DaCapo rechargeable<br />
battery system.<br />
2005 Introduction<br />
of the meD-el<br />
DUet eas <br />
speech processor<br />
in Europe, the first<br />
hearing implant<br />
system worldwide<br />
to integrate cochlear<br />
implant audio<br />
processing and<br />
acoustic amplification<br />
in one compact<br />
device.<br />
2006 launch of the<br />
opUs processors.<br />
the <strong>sonatatI</strong> 100<br />
cochlear implant,<br />
with small titanium<br />
housing, and the<br />
fleX electrode for<br />
all implant types are<br />
introduced.<br />
the hearing Implant Company<br />
2009 eas in the<br />
2 nd generation.<br />
european launch of<br />
the DUet 2 audio<br />
processor. amadé,<br />
the new audio<br />
processor of the<br />
Vibrant soundbridge<br />
is introduced in<br />
europe.<br />
2008 the new<br />
maestro 3.0<br />
system software<br />
approved in europe.<br />
the opUs processors<br />
are now also available<br />
for ComBI 40+<br />
implant users.<br />
19
20332 r.4.1<br />
MED-EL GmbH<br />
Niederlassung Wien<br />
liechtensteinstr. 22a<br />
1090 Wien, austria<br />
office@at.medel.com<br />
MED-EL Deutschland GmbH<br />
moosstr. 7, 2. oG<br />
82319 starnberg, Germany<br />
office@medel.de<br />
MED-EL Deutschland GmbH<br />
Büro Berlin<br />
schloßstr. 57<br />
14059 Berlin, Germany<br />
office-berlin@medel.de<br />
MED-EL Deutschland GmbH<br />
Office Helsinki<br />
Valimotie 13a<br />
00380 helsinki, finland<br />
office@fi.medel.com<br />
MED-EL Unità Locale Italiana<br />
Via maso della pieve 60/a<br />
39100 Bolzano (BZ), Italy<br />
ufficio.italia@medel.com<br />
VIBRANT MED-EL<br />
Hearing Technology France<br />
Village d‘entreprise Green side<br />
400 av roumanille - Bp 309<br />
06906 sophia-antipolis Cedex<br />
france<br />
office@fr.medel.com<br />
MED-EL GmbH Sucursal España<br />
Centro empresarial euronova<br />
ronda de poniente num.2, 2°a<br />
tres Cantos<br />
28760 madrid, spain<br />
office@es.medel.com<br />
MED-EL GmbH<br />
Sucursal em Portugal<br />
av. sá da Bandeira,<br />
77 – 1° Dt° fte.<br />
3000 – 351 Coimbra, portugal<br />
office@pt.medel.com<br />
MED-EL UK Ltd<br />
Great Cliffe Court, Dodworth<br />
Barnsley, s75 3sp, UK<br />
office@medel.co.uk<br />
The Hearing Implant Company<br />
MED-EL <strong>El</strong>ektromedizinische Geräte GmbH<br />
Worldwide headquarters<br />
fürstenweg 77a<br />
6020 Innsbruck, austria<br />
office@medel.com<br />
MED-EL Corporation<br />
North America<br />
2511 old Cornwallis road, suite 100<br />
Durham, nC 27713, Usa<br />
implants@medelus.com<br />
MED-EL Latino America S.R.L.<br />
Viamonte 2146 p 9<br />
(C1056aBh) Capital federal,<br />
argentina<br />
medel@medel.com.ar<br />
MED-EL Middle East FZE<br />
Dubai airport free Zone<br />
p.o. Box 54320, 54321 Dubai,<br />
United arab emirates<br />
medeluae@emirates.net.ae<br />
MED-EL India Private Ltd<br />
#505 pragati house<br />
47-48 nehru place<br />
new Delhi, 110019 India<br />
implants@medel.in<br />
MED-EL Hong Kong<br />
hQ asia pacific<br />
room 1301, ashley nine<br />
9-11 ashley road, tsim sha tsui<br />
Kowloon, hong Kong sar<br />
office@hk.medel.com<br />
MED-EL Philippines HQ<br />
1501 richville Corporate tower<br />
Industry road<br />
madrigal Business park<br />
ayala alabang, muntinlupa City<br />
rp-1702 philippines<br />
office@ph.medel.com<br />
MED‑EL China Office<br />
Unit 1012, tower D,<br />
soho new town,<br />
no.88 Jianguo road,<br />
Chaoyang District,<br />
Beijing,100022, pr China<br />
office@medel.net.cn<br />
MED-EL Vietnam<br />
23 nguyen son ha<br />
Ward 5, District 3<br />
ho Chi minh City, Vietnam<br />
office@vn.medel.com<br />
MED-EL Thailand<br />
202 le Concorde tower<br />
6th floor, room 605<br />
ratchadapisek road<br />
huaykwang District<br />
Bangkok 10310, thailand<br />
office@th.medel.com<br />
MED-EL Malaysia<br />
n8 & n9, Ground floor<br />
CmC Centre, Jalan Cerdas<br />
taman Connaught, Cheras<br />
56000 Kuala lumpur, malaysia<br />
office@my.medel.com<br />
MED-EL Singapore<br />
41 science park road<br />
the Gemini, lobby B #04-03a<br />
singapore science park II<br />
singapore 117610<br />
office@sg.medel.com<br />
MED-EL Indonesia<br />
Jalan perkici 17 Blok<br />
eB 15 no 32, sektor 5<br />
Bintaro Jaya, tangerang<br />
Indonesia<br />
office@ind.medel.com<br />
MED-EL Korea<br />
room 706, Jeil Building,<br />
#256-13, Gongduk-dong, mapo-ku<br />
seoul 121-803, republic of Korea<br />
office@kr.medel.com<br />
MED-EL Japan Co., Ltd<br />
7f tIK Bldg., 3-2-3 hongo<br />
Bunkyo-ku<br />
tokyo, 113-0033 Japan<br />
info@medel.co.jp<br />
MED‑EL Liaison Office<br />
Australia-NZ<br />
Cottesloe Central, 1st floor<br />
460 stirling highway<br />
Cottesloe (perth), Wa 6011<br />
australia<br />
office@au.medel.com<br />
www.medel.com
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