1. NYU Cochlear Implant Center Department of Otolaryngology
An Introduction to Cochlear Implants
Susan B. Waltzman, PhD
Marica F. Vilcek Professor of Otolaryngology
Co-Director, NYU Cochlear Implant Center
NYU Cochlear Implant Center Department of Otolaryngology

2. Disclosures Financial: Salary from NYU School of Medicine
VA Rehabilitation Research & Development (RR&D) Auditory Vestibular Research Enhancement Award Program (AVREAP) honorarium
Royalties from textbook.
Non-Financial: No non-financial relationships exist.

3. Learner Objectives Participants will be able to:
1. Describe current cochlear implants
2. Summarize current candidacy criteria
3. Discuss processing strategies

4. History of the Cochlear Implant
Precursors
Vocoder- Homer Dudley (Bell Labs)
1939- real time voice synthesizer that produced intelligible speech using circuitry designed to extract the F0 of speech, the intensity of its spectral components, and overall power. Components extracted with a series of 10 band pass filters- called a vocoder.
Cochlear Microphonic- Wever and Bray-
1930- produced and described the electrical potentials in the cochlea that faithfully reproduced the sound stimulus
Electrophonic hearing- S.S. Stevens, et al
1930’s described the mechanism by which the cochlear elements respond to electrical stimulation to produce hearing
Eisen, M. History of Cochlear Implants
In Cochlear Implants. Ed. Waltzman and Roland 2014

5. History of the Cochlear Implant
Djourno and Eyries first reported direct stimulation of the cochlear nerve - facial nerve graft-patient eventually could differentiate high v. low, environmental sounds, etc. Chouard (Eyries lab)- credited with development the first multi-channel CI, in Europe.
Eisen, M. History of Cochlear Implants
In Cochlear Implants. Ed. Waltzman and Roland 2014

6. History of the Cochlear Implant
US William House (L.A.) received English translation of D&J work 1st CI January into the round window. F. Blair Simmons (Stanford) Robin Michelson (San Francisco)- single/multichannel Mike Merzenich- UCSF (AB device) By interest began to grow Graham Clark. Nucleus device in US
Eisen, M. History of Cochlear Implants
In Cochlear Implants. Ed. Waltzman and Roland 2014

7. Auditory Function in Patients with Severe-to-Profound SNHL
Sensory receptors for audition (hair cells) are damaged or significantly diminished in number
Some auditory nerve fibers survive
Damaged hair cells are unable to transmit electrical impulses to surviving nerve fibers
Auditory perception severely distorted or not possible

8. How Hearing Aids Work Hearing aids are designed to make sounds louder
These amplified sounds are then sent through the damaged part(s) of the ear
In some cases of sensorineural hearing loss, hair cell damage can be so extensive that these amplified sounds are too distorted to be useful for speech understanding
For these patients, a cochlear implant may be the answer
For many patients, hearing aid amplification is a sufficient means to hear and understand spoken language, but for those with severe to profound hearing loss even the most sophisticated power hearing aids may not provide enough auditory information for the person to achieve a level of speech understanding that we or they would consider “useful hearing”. Keep in mind that “useful hearing” will mean different things to different people.

9. Common Principles of all Cochlear Implant Systems
In sensorineural deafness, viable auditory nerve tissue survives. Signals are not conveyed because the sensory receptors (hair cells) are damaged and unable to transmit electrical impulses to the nerves
Cochlear implants are designed to bypass the damaged hair cells and stimulate the auditory nerves directly through the introduction of external electrical current.
All implant systems share the same goal and, therefore, the same task.

10. To convert the acoustic input signal into an electrical pattern that yields sound/speech clarity and allows speech recognition.
All implant systems operate similarly-microphone > processor > antenna/transmitter > receiver/stimulator > electrode array

11. Design Features Transmission speed Electrode design
Number of electrode contacts
Number of channels
Speech coding strategy

12. Speech coding strategy
A set of rules for converting the acoustic signal into a stream of electrical stimulating waveforms applied by a cochlear prosthesis

13. Normal Hearing Sound vibratory energy
mechanical energy transformed to electrical nerve depolarization

14. Cochlear Implant

16. Evolution: The Implantable Cochlear Stimulator (ICS)
1.0
Investigational
Prior to 1995
1.2
1996
CII Bionic
Ear™
2001
HiRes™ 90K
2003
HiRes™ 90K Advantage
2012
The internal cochlear stimulator (ICS), the component placed by the surgeon into the mastoid area behind the ear, has evolved in both circuitry and design. As shown above, until approximately 2003, the internal component was manufactured with a ceramic case, or CIM – Ceramic Injection Mold. In 2003, AB introduced the HiRes 90K utilizing titanium and silastic materials. The 1.0 was designed for investigational purposes and few are in use today. Although there are a significant number 1.2, or C1, recipients supported by AB, you are most likely to work with the CII and HiRes 90K devices in your clinics. All new AB recipients will receive the most current ICS, which for now is the HiRes 90K. Therefore, we will focus in this workshop on programming and management of the CII and HiRes 90K devices, as well as the sound processors supported by these two internal components. Your clinical specialist and ABs on-call support team as readily available to provide direct support with a C1 patient as needed.
What makes AB unique is the sophisticated technology housed within these devices. This advanced technology has allowed AB’s products to be designed with technological headroom so that software upgrades are possible without requiring surgery to replace the internal device. This means that current AB recipients can take advantage of tomorrow’s sound processing innovations.

17. Evolution: The Sound Processor
Freestyle
Off the Ear
Neptune™
BTE
Advances in technology have also been applied to the Sound Processor, which has the responsibility of capturing and coding sound for delivery to the internal stimulator. As sound processing technology advanced, the size of the device decreased – by 94% since the Clarion 1.0 – which is remarkable considering that AB recipients have benefited from several generations of advancements in sound processing strategies, each offering a richer access to the sound they want to hear. Today you will primarily encounter recipients of the Netpune Sound Processor, Harmony sound processor, and Platinum Sound Processor. Less frequently, you will work with the HiRes Auria, or the Platinum BTE.
Staff: note the current availability and sun-setting plans for processors.
Harmony™
Naída CI Q70 & Q90

18. `86 `97 `99 `05 `09 5th generation Nucleus® implant CI24M Contour™
Freedom™
CI512
Summary

19. 9th generation Nucleus® sound processor
`83
`89
`94
`98
`01
`02
`05
`09
`13
WSP
MSP
Spectra
SPrint™
ESprit™
ESprit 3G
Freedom™
CP810
CP910
Summary

20. Processor advancements
Freedom device

21. Cochlear™ Nucleus® Electrode Portfolio
CONTOUR ADVANCE™ ELECTRODE
SLIM STRAIGHT ELECTRODE
HYBRID™ L24 ELECTRODE
It should be noted that the CI422 receiver/stimulator is equivalent to the receiver/stimulator used on the CI24RE Series.
STRAIGHT ELECTRODE
DOUBLE ARRAY ELECTRODE
AUDITORY BRAINSTEM ELECTRODE

22. 4/28/2017
SONNET and RONDO are compatible with all previous and current MED-EL implants
MED-EL CONCERT
C40+
PULSAR
SONATA
2015
1997
SYNCHRONY*
Animation:
The first FDA approved MED-EL implant was the COMBI 40+ (C40+), introduced here in 1997 and used through The C40+ has 12 channels stimulating at pps, back telemetry, and a remote ground. It is MRI conditional at 0.2T and MED-EL is currently actively pursuing 1.5T MRI approval for this implant today. C40+ recipients can take advantage of RONDO and SONNET audio processors and can enjoy the FSP and FS4 coding strategies.
PULSAR (2005 in the US): New i100 electronics platform offered the ability to stimulate at maximum 50,704 pps, with fully independent current sources that would in the future allow parallel stimulation. PULSAR recipients can use all current processors as well as all current coding strategies. PULSAR can undergo MRI at 1.5T; it has a non-removable magnet.
The SONATA (2007 in the US) implant introduced a titanium housing, and can undergo MRI at 1.5T with non-removable magnet.
The MED-EL CONCERT (2011 in US) implant introduced the option of the pin housing, for improved implant immobilization, as well as a 25% thinner, yet stronger, housing; 1.5T MRI with non removable magnet. The SYNCRHONY implant, introduced in 2015, brings the revolutionary diametric magnet design, which rotates in an MRI unit to allow MRI at 1.5 and 3T with the magnet in place. The SYNCRHONY magnet is optionally removable if the area immediately surrounding the implant needs to be imaged.
© MED-EL

23. 4/28/2017
SONNET and RONDO are compatible with all previous and current MED-EL implants
SONNET
Animation:
CISPRO+ processor 1996: 2 AA batteries, 2 days battery life, 3 programs, 2 LED lights for troubleshooting, input for ALDs, volume and sensitivity control on the processor/headpiece.
TEMPO+ 1998: Worlds first modular processor with 7 different wearing options, pediatric wearing options, 9 program slots, volume, sensitivity and program selector on the processor, special battery pack for direct FM input or ALDs, rechargeable AA battery pack, DaCapo ear-level rechargeable battery pack
OPUS 1 & 2 (2008/2009): Introduction of the world’s first CI Fine Tuner remote control, no switches on the processor but volume, sensitivity, 4 programs and built-in telecoil activation from the Fine Tuner; bilateral control of two processors with one button, private alert, IRIS (individual recognition of the implant system to ensure bilateral users connect to the correct processor). Also offered the OPUS 2 XS extra small battery option, as well as DaCapo rechargeable option. OPUS 1 provided an option for switches on the processor but most patients selected OPUS 2. The OPUS family introduced the capacity for Fine Structure Processing.
RONDO (2013): worlds first single-unit processor, all the same features of the OPUS 2 in one unit (aside from wearing/battery options). With WaterWear cover, it is IP68
SONNET AP (2015): IP 54, tamper-proof battery pack, Fine Tune remote control, bimodal streaming via Quattro interface, bluetooth via Quattro, 2.4GHz enabled for future wireless platform, integrated datalogging. Future-ready for additional front-end processing using 2 microphones, not yet FDA approved in the USA.
RONDO
CISPRO+
TEMPO+
OPUS 1 & 2
2015
1996
© MED-EL

24.
MED-EL Electrode Arrays Classic Series: Wave-shaped wires for atraumatic insertion properties
The“Classic“ series of electrode designs (standard, medium and compressed) were introduced in 1996 with the first implants brought to the US. The standard, a 31 mm electrode length, was used in most patients, while the medium at 24 mm provided an option for slightly shorter cochlear duct lengths or reimplantations where a shorter electrode was being removed. The compressed electrode at 15 mm was intended for significantly smaller cochleaes, mondini malformation, etc. A split array (not shown) is also available which offers two arrays, one with 5 channels and the other with 7, intended for implantation into fully ossified cochleae; in this case, the surgeon drills two cochleostomies and typically two straight tunnels – one array is implanted in the upper basal turn and the other implanted in the lower basal turn to give the patient the best chance at stimulation surrounding the modiolus.
© MED-EL

25.
MED-EL Electrode Arrays FLEX Series: Further designed for structure preservation using FLEX Tip Technology
The FLEX electrode series was introduced in 2011 and were further refined for atraumatic insertion characteristics. Still using the same patented wave-shaped wiring, the FLEX series of electrodes minimize the volume of the apical end by using single contacts instead of pairs for the 5 most distal electrode channels. This results in a thinner, more flexible apical tip designed for preservation of delicate cochlear structures.
© MED-EL

26. ? ? ? ? Candidacy Evolution ? 2016 Peds Scores Adult Scores (open-set)
Lack of aud. Progress
(MAIS, < 30% (MLNT/LNT)
(depending on age)
Less than 20%
0% open-set
Not candidates
Peds Scores
50% or less (HINT) in ear to be implanted with 60% or less in contralateral ear or binaurally
40% or less (CID) 0%
Adult
Scores (open-set)
Severe-Profound Patients
– 2 yrs & older
Profound Children
– younger than 2 yrs
Severe-Profound Adults
Profound
Degree
of SNHL
Adults & Children
Pre & Postlinguistic
Postling. Adults Pre & Postling. Children
Postlinguistic
Onset of
Hearing Loss
(12 mo)
(18 mo)
(2 yrs)
Adults
(18 yrs)
Age of
Implantation
2000
1998
1990
1985 ? ? ? ? ?

27. Areas of Expansion Age at implantation Younger than one year old
Adolescents and adults with prelingual deafness
Geriatric
More residual hearing
Long-term deafened
Multiple disabilities and auditory neuropathy
Bilateral implantation
SSD
EAS
ABI for other than NF2

28. Areas of Expansion Bimodal stimulation Knowledge of HA programming
CI + HA
CI +ABI
Manufacturer specific programming guidelines

29. Areas of Expansion Medical/Surgical Complicating Factors
Malformed and hypoplastic cochleae
Obstructed cochleae
Complicating diseases
HIV, severe conditions
Streamlined fittings
Greater numbers of patients
Time, financial constraints
Self fitting
Group fittings
I techs

30. Evaluation Process History Audiologic battery
Speech perception battery
Medical, Otologic, Radiographic
Vestibular
Questionnaires
Psychological, social work
Counseling
AT LEAST YEARLY EVALUATIONS POST-IMPLANTATION

31. Adult Candidacy 18 years of age or older
Bilateral severe/profound sensorineural hearing loss (could be moderate in low frequencies)
Limited benefit from amplification (<50% in the ear to be implanted and <60% in the opposite ear or binaurally on sentences)

32. Adult Preoperative Evaluation
Unaided and aided thresholds
Speech perception battery (words, sentences, quiet, noise, each ear, bilateral)
Medical
Otologic
Radiologic
Vestibular (?)
ABR (?)
Family/support
Counseling
Realistic expectations
Device counseling

33. Pre and Post-operative Protocol
Unaided audiogram, SDT, SRT, speech discrimination each ear
Impedance
Otoacoustic emissions
Aided thresholds, SDT, SRT
CNC words, HINT or AzBio sentences in quiet and noise presented at 48dBHL. HINT at SNR+10, AzBio at SNR+5
Evaluations are done in each ear individually and bilaterally.

34. Prelingual Adult
Add or substitute as needed A, V, A+V and preop with hearing aids each ear and bilaterally (postop with implants)
Tests: CID sentences, noise/voice, male/female, number of syllables, etc.

35. Bilateral Adult: simultaneous and sequential preop and postop
Each ear separately and binaural
Same tests adding the BKB-SIN test with speech coming from the front and noise front, right, left.

36. Other
Localization testing for bilateral and unilateral candidates

37. Special Protocols
Bilateral
Hybrid
Unilateral (SSD)
Clinical Trials

38. Hybrid L24 Hybrid L24: Viable option for the “in-between” patient
Conventional, FLT, &
implantable HAs
Cochlear Implantation
I have dedicated my professional practice and research to this special population of patients for over a decade. I have fit these patients with every hearing aid imaginable and have directly experienced the frustration of these individuals who live within this technological gap.

39. Traditional CI vs. Hybrid Candidates
Current Indications for CI
Hybrid Candidacy Criteria
≤ 50% HINT sentences in ear to be implanted
≤ 60% HINT in contralateral ear or best aided condition
Aided CNC > 10% but  60% in ear to be implanted
80% CNC in the contralateral ear

40. Pre-operative Evaluation (Pediatric)
Case history
Medical, otologic, audiologic, communication, educational, and psycho-social factors
Audiologic- unaided and aided testing
behavioral measures
objective measures
ABR, OAE
Age appropriate speech perception testing
Medical
Otologic
Radiologic
Assessment of speech and language development
Assessment of cognitive development
Family and school support
Counseling- expectations

41. Choosing a Device
It is the Center’s responsibility to provide accurate information re: all devices and answer questions
Reliability data, ease of use, etc.
Patient then makes an informed decision

42. Common Questions
Which is the best device? 50% will choose a device because it’s new, 50% will not choose a device because it’s new
Reimbursement
Know someone with a particular device
Marketing
Cosmetics

43. Common Questions MRI compatibility Battery life Ergonomics
Customer support
Company stability

44. Future Advancements Totally implantable
Internal/external components e.g. waterproof
Totally implantable
New approaches to processing e.g. top-down, pre-processing
Electrode design
Surgery e.g. robotic
Drugs
Training