10. Middle Ear Implants & Auditory Brainstem Implants_stu.pptx

MIDDLE EAR IMPLANTS & AUDITORY BRAINSTEM IMPLANTS  IMPLANTABLE MIDDLE EAR DEVICES  IMPLANTABLE MIDDLE EAR DEVICES Traditional Hearing Aid AMPLIFICATION DEVICE IN WHICH VIBRATIONAL ENERGY IS DELIVERED TO Middle Ear Implant...

MIDDLE EAR IMPLANTS & AUDITORY BRAINSTEM IMPLANTS  IMPLANTABLE MIDDLE EAR DEVICES  IMPLANTABLE MIDDLE EAR DEVICES Traditional Hearing Aid AMPLIFICATION DEVICE IN WHICH VIBRATIONAL ENERGY IS DELIVERED TO Middle Ear Implant THE EAR USING IMPLANTED COMPONENTS HISTORY OF MIDDLE EAR IMPLANTS WILSKA (1935) EXPERIMENTED WITH IRON PARTICLES PLACED ON TM GENERATED MAGNETIC FIELD TO VIBRATE TM RUTSCHMANN (1959) STIMULATED OSSICLES BY GLUING 10MG MAGNETS TO UMBO GENERATED MAGNETIC FIELD TO VIBRATE OSSICLES IMPLANTABLE MIDDLE EAR DEVICES DESIGNED FOR: MODERATE TO SEVERE HL PEOPLE UNABLE TO ACHIEVE ADEQUATE BENEFIT OR MEDICALLY UNABLE TO TOLERATE HAS MAYBE THEY DON’T HAVE A PINNA OR DON’T LIKE THE LOOK OF HEARING AIDS IMPROVE FIDELITY IMPROVE COMFORT ELIMINATE FEEDBACK= MOST BUT NOT ALL. THIS WAS A BIG ISSUE WITH BONE DEVICES IMPROVE COSMETICS SWIMMING/BATHING TYPES OF DEVICES PIEZOELECTRIC DEVICES ELECTROMAGNETIC DEVICES SEMI-IMPLANTABLE TOTALLY-IMPLANTABLE PIEZOELECTRIC DEVICES  PIEZOELECTRIC DEVICES ELECTRIC CURRENT CHANGES VOLUME OF PIEZO-CERAMIC CRYSTAL, PRODUCING VIBRATORY SIGNAL POWER OUTPUT RELATED TO SIZE OF CRYSTAL REQUIRES 2 POINTS OF CONTACT OSSICLES= TRANSFERS THE VIBRATION MASTOID= RECEIVES THE CURRENT TWO CONFIGURATIONS MONOMORPH= DIRECTLY STIMULATE TO CAUSE THE DEFORMATION BIMORPH= TWO PIECES TOGETHER THAT STIMULATE TO CAUSE THE DEFORMATION MRI COMPATIBLE PIEZOELECTRIC DEVICES (3 DIFFERENT KINDS) RION DEVICE E-TYPE (RDE) THE TOTALLY INTEGRATED COCHLEAR AMPLIFIER (TICA) ESTEEM RION DEVICE E-TYPE (RDE) PARTIALLY IMPLANTED DEVICE: INTERNAL UNIT: OSSICULAR VIBRATOR MAGNETIC COIL CONNECTED WITH A WIRE TO CREATE A MAGNETIC FIELD BETWEEN THE EXTERNAL COIL EXTERNAL COMPONENTS: MICROPHONE, AMPLIFIER, EXTERNAL COIL, BATTERY USED FOR BOTH CONDUCTIVE AND SNHLS WORKED BY PASSING ELECTRIC CURRENT INTO PIEZOCERAMIC CRYSTAL ATTACHED TO STAPES NOT VERY POWERFUL; DECREASED EFFICACY WITH TIME RION DEVICE E-TYPE Yanagihara N et al. (1987). Implantable hearing aid: Report of the first human applications. Arch  TOTALLY. INTEGRATED. COCHLEAR. AMPLIFIER (TICA) https://thehealthscience.com/node/1216010 THE TOTALLY INTEGRATED COCHLEAR AMPLIFIER (TICA) - IMPLEX COMMERCIALLY AVAILABLE IN EUROPE IN 1999 USED IN EUROPE MOSTLY FOR MODERATE-SEVERE HIGH FREQUENCY SNHL EXTERNAL COMPONENTS TICA REMOTE CONTROL CORDLESS TICA CHARGER YOU HAVE TO CHARGE THE DEVICE THAT IS IN YOUR BODY  TOTALLY IMPLANTABLE COCHLEAR AMPLIFIER (TICA) INTERNAL COMPONENTS RECHARGEABLE BATTERY (LITHIUM ION) MICROPHONE (SUBCUTANEOUS) SPEECH PROCESSOR (SUBCUTANEOUS) PIEZOELECTRIC TRANSDUCER EXTERNAL HARDWARE BATTERY RECHARGER BATTERY LIFE OF 5 YEARS AND THEN AFTER THAT IT WOULD NEED TO BE CHANGED OUT ON/OFF VOLUME/SENSITIVITY http://thehealthscience.com TOTALLY IMPLANTABLE COCHLEAR AMPLIFIER (TICA) BENEFITS NO EXTERNAL PARTS ABLE TO “HIDE DEAFNESS” NO CABLES, MICS... TO BREAK ABLE TO HEAR 24 HRS A DAY TOTALLY IMPLANTABLE COCHLEAR AMPLIFIER (TICA) DISADVANTAGES LARGE INTERNAL DEVICE BATTERY HAS TO BE SURGICALLY REPLACED HEAR “BODY NOISES” (BREATHING, SWALLOWING) UNRESOLVED FEEDBACK PROBLEMS ESTEEM HEARING IMPLANT (ENVOY MEDICAL) https://www.envoymedical.com/esteem  ESTEEM HEARING IMPLANT Sound processor implanted behind the ear Drive Sens r or Sensor & Driver attached to ossicular chain Anderson, L. (2014, July). The Esteem® Hearing Implant. AudiologyOnline, Article 12780. Retrieved from:  ESTEEM COMPONENTS SENSOR: SENSES VIBRATION FROM INCUS AS INPUT SIGNAL SIMILAR TO A MICROPHONE IN A TRADITIONAL HA, IT GETS THE SIGNAL SOUND PROCESSOR: PROCESSES AND AMPLIFIES ACOUSTIC SIGNALS ACCORDING TO PROGRAMMED SETTINGS AND ALGORITHMS DRIVER: DELIVERS AMPLIFIED SIGNAL AS VIBRATIONS TO STAPES SOUND SENSOR PROCESSO DRIVER (Input) R (Output) (Gain) ESTEEM COMPONENTS Driver Senso Sound r Process or Anderson, L. (2014, July). The Esteem® Hearing Implant. AudiologyOnline, Article 12780. Retrieved from:  USES TM AS NATURAL MICROPHONE ADVANTAGES: LESS PROCESSING OF INPUT SOUND RETENTION OF NATURAL RESONANCES OF EAR Influence of pinna (p) and ear canal (c) on the amplitude of the signal reaching the ear drum. At 3000 Hz, the final amplification (t) is 20 dB (10 times the free field level) Pujol, R, et al. ESTEEM SYSTEM FEATURES CUSTOM INTEGRATED CIRCUITRY LOW ENERGY REQUIREMENTS FREQUENCY RANGE 200 - 6000 HZ SYSTEM GAIN UP TO 50 DB NON-MAGNETIC SOUND PROCESSOR IS 6.4 MM THICK; HOUSES THE BATTERY & PROCESSOR LITHIUM IODINE BATTERY LIFE OF 4.5 - 9 YEARS (MEDIAN 5.5 YEARS) PIEZOELECTRIC TRANSDUCERS SENSOR – DISPLACEMENT OF INCUS DEFLECTS SENSOR, PRODUCES ELECTRICAL SIGNAL SENT TO SOUND PROCESSOR Sensor DRIVER – ELECTRICAL SIGNAL FROM SOUND PROCESSOR DEFLECTS DRIVER, TRANSFERRING VIBRATION TO STAPES KEY BENEFITS ULTRA-LOW POWER LOW DISTORTION, EVEN AT MAX OUTPUT LEVELS VERY LOW NOISE Driver TITANIUM ENCLOSURE 100% HERMETICALLY SEALED = THE SOUND PROCESSOR  SOUND PROCESSOR DIGITALLY- PROGRAMMABLE ANALOG RECEIVES ELECTRICAL SIGNAL FROM SENSOR, PROCESSES SIGNAL, AND SENDS MODIFIED SIGNAL TO DRIVER Esteemhearing.com  SENSOR ABUTS BODY OF INCUS CONNECTED TO SOUND PROCESSOR BY DETACHABLE LEAD, SO THEY COULD BE REPLACED IF SOMETHING HAPPENS TO IT Esteemhearing.com DRIVER CONNECTED TO STAPES CONNECTED TO SOUND PROCESSOR BY DETACHABLE LEAD HERMETIC TITANIUM ENCLOSURE Esteemhearing.com PERSONAL PROGRAMMER Trans mit Query Volum Profile e Up Standby Volume Down Personal Low Programmer Battery Low Battery Light Light Esteemhearing.com INDICATIONS FOR USE 18 YEARS OF AGE OR OLDER STABLE BILATERAL MODERATE TO SEVERE SNHL UNAIDED SPEECH DISCRIMINATION ≥ TO 40% NORMAL MIDDLE EAR ANATOMY AND FUNCTION ADEQUATE SPACE FOR THE IMPLANT MINIMUM 30 DAYS EXPERIENCE WITH APPROPRIATELY FIT HAS IDEAL FITTING RANGE B A S E L I N E P U R E -T O N E T H R E S H O L D S Anderson, L. (2014, July). The Esteem® Hearing Implant. AudiologyOnline, Article 12780. Retrieved from: CONTRAINDICATIONS/ WHO IS NOT A CANDIDATE HISTORY OF CHRONIC OTITIS MEDIA, OTITIS EXTERNA, ECZEMA, KELOIDS, CHOLESTEATOMA OR DESTRUCTIVE MIDDLE EAR DISEASE FLUCTUATING HL OF 15 DB AT 2 OR MORE FREQUENCIES HISTORY OF INNER EAR DISORDERS, OR RECURRING VERTIGO REQUIRING TREATMENT RETROCOCHLEAR OR CENTRAL AUDITORY DISORDERS DISABLING TINNITUS HYPERSENSITIVITY TO SILICONE RUBBER, POLYURETHANE, STAINLESS STEEL, TITANIUM, AND/OR GOLD PRE-EXISTING MEDICAL CONDITION OR UNDERGOING A TREATMENT THAT MAY AFFECT HEALING PREGNANCY SETTING EXPECTATIONS ESTEEM WILL NOT RESTORE NORMAL HEARING MAY PROVIDE MORE BENEFIT THAN PATIENT’S CURRENT HA ESTEEM CANNOT ALWAYS MATCH PERFORMANCE OF A WELL‐FIT HA AVERAGE MAX AIDED GAIN: 40‐45 DB AVERAGE PTA GAIN: ~ 26 DB MAX POWER OUTPUT: 100 DB SPL  SURGERY 1. CT SCANS 2. CREATE THE SOUND PROCESSOR BED 3. PERFORM MASTOIDECTOMY & ATTICOTOMY 4. MEASURE INTACT OSSICULAR CHAIN DISPLACEMENT 5. RESECT INCUS LONG PROCESS AND PREPARE STAPES 6. POSITION SENSOR AND DRIVER TRANSDUCERS 7. CEMENT TRANSDUCERS IN PLACE 8. CONDUCT INTRA-OPERATIVE TESTING OF COMPONENTS & SYSTEM  FITTING PRESCRIPTIVE GAIN TARGETS PROVIDE AIDED HTL GUIDANCE IN FITTING AMPLIFICATION 5 15 25 3 2 35 35 UNAIDED HTL VERIFICATION LIMITED TO BEHAVIORAL MEASURES (AIDED GAIN) FITTING PARAMETERS Anderson, L. (2014, July). The Esteem® Hearing Implant. AudiologyOnline, Article 12780. Retrieved from:  RISKS EROSION OF SOUND PROCESSOR THROUGH SKIN INFECTION TO SOUND PROCESSOR POCKET DETERMINATION DURING SURGERY THAT ANATOMY DOESN’T ALLOW ENOUGH SPACE FOR IMPLANT INTRAOPERATIVE INJURY TO MALLEUS, INCUS, STAPES OR COCHLEA COLDS, SINUS, AND UPPER RESPIRATORY CONGESTION REDUCES BENEFIT OR CAN IMPACT DEVICE LIMITED OR NO BENEFIT, THERE ARE NO GUARANTEES MECHANICAL FEEDBACK LOSS OF ATTACHMENT OF LEADS/TRANSDUCERS FROM MASTOID/OSSICLES DISLOCATION OF OSSICLES BLEEDING AND POSTOPERATIVE INFECTION LOSS OF HEARING IN EVENT OF DEVICE EXPLANT ESTEEM: FUNCTIONAL GAIN Anderson, L. (2014, July). The Esteem® Hearing Implant. AudiologyOnline, Article 12780. Retrieved from: http://www.audiologyonline.com ESTEEM: SPEECH TESTING Anderson, L. (2014, July). The Esteem® Hearing Implant. AudiologyOnline, Article 12780. Retrieved from: QUALITY OF LIFE FDA (2009). PMA P090018: FDA Summary of Safety and Effectiveness Data. ELECTROMAGNETI C DEVICES  ELECTROMAGNETIC DEVICES ELECTRIC CURRENT PASSES INTO A COIL, CREATING A MAGNETIC FLUX THAT DRIVES AN ADJACENT MAGNET MAGNET IS ATTACHED TO OSSICULAR CHAIN NOT MRI COMPATIBLE BC WE’RE TALKING MAGNETS. THE ESTEEM IS MRI COMPATIBLE HOWEVER POWER IS DECREASED BY THE SQUARE OF THE DISTANCE BETWEEN THE COIL AND MAGNET SHIFTS IN POSITION CAN DECREASE THE POWER DISTANCE IMPACTS POWER  ELECTROMAGNETIC DEVICES MIDDLE EAR TRANSDUCER (MET) SOUNDTEC DIRECT SYSTEM OTOTRONIX MAXUM VIBRANT SOUNDBRIDGE DEVICE OTOLOGICS CARINA MIDDLE EAR TRANSDUCER (MET) INITIALLY SEMI-IMPLANTABLE; THEN TOTALLY IMPLANTABLE CONSISTS OF IMPLANT, PROGRAMMING SYSTEM, CHARGER & REMOTE CONTROL MICROPHONE PICKS UP SIGNAL, SENDS TO TRANSDUCER COUPLED DIRECTLY TO OSSICULAR CHAIN http://thehealthscience.com/thsattachs/ CARINA MET Traynor & Frederickson. (2007). The Future is Here: The Otologics Fully Implantable System.  CARINA MET Traynor & Frederickson. (2007). The Future is Here: The Otologics Fully Implantable CARINA MET Traynor & Frederickson. (2007). The Future is Here: The Otologics Fully Implantable CARINA MET Traynor & Frederickson. (2007). The Future is Here: The Otologics Fully Implantable CARINA MET Traynor & Frederickson. (2007). The Future is Here: The Otologics Fully Implantable CARINA MET SOUNDTEC DIRECT SYSTEM http://thehealthscience.com/thsattachs/ 904911/111907341833965.jpg SOUNDTEC DIRECT SYSTEM SEMI-IMPLANTABLE DEVICE CONVERTS SOUND ENERGY TO ELECTROMAGNETIC ENERGY TO DIRECTLY STIMULATE OSSICLES SURGICALLY IMPLANTED MAGNET ATTACHED TO OSSICULAR CHAIN EARMOLD COIL ASSEMBLY STIMULATES THE MAGNET EARMOLD COIL IS ATTACHED TO A SOUND PROCESSOR FITS EITHER ITC OR BTE http://bmelab.ou.edu/impt%20dvcs.htm SOUNDTEC DIRECT SYSTEM ADVANTAGES DISADVANTAGES DOES NOT REQUIRE ACOUSTIC REQUIRES SEPARATION & RECONSTITUTION OF INCUDOSTAPEDIAL JOINT SEAL SEVERING THE JOINT AND THEN PUTTING IT BACK TOGETHER AIDED GAIN IMPROVED WITHOUT YOU LOSE SOME OF THE CONNECTION BY PRECIPITATING FEEDBACK SEVERING IT SO ITS NEVER THE SAME AGAIN LOSS OF AVERAGE BONE CONDUCTION AFTER IMPLANTATION SOUNDTEC DIRECT SYSTEM OUTCOMES WHILE SOUNDTEC DID NOT PROVIDE A SIGNIFICANT DIFFERENCE FROM OPTIMAL TRADITIONAL AMPLIFICATION, IT PROVIDED STATISTICALLY SIGNIFICANT HIGH-FREQUENCY AIDED GAIN (~26 DB GAIN) SUBJECTIVE REPORTS INDICATED A CLEANER, MORE NATURAL SOUND WITHOUT FEEDBACK THAN THAT ACHIEVED WITH TRADITIONAL AMPLIFICATION DEVICE VOLUNTARILY WITHDRAWN FROM MARKET IN 2004 PURCHASED BY OTOTRONIX IN 2009 OTOTRONIX MAXUM Impla nt Integrated Processor/ Transceiver Coil McCraney & Glasscock. (2015). Bridging the Gap Between Hearing Aids and Cochlear Implants: Middle Ear  OTOTRONIX MAXUM TWO COMPONENTS IMPLANT INTEGRATED PROCESSOR & COIL (IPC) IPC SOUND PROCESSOR SENDS ELECTRIC SIGNALS TO TRANSCEIVER COIL WHICH IS CONVERTED TO ELECTROMAGNETIC SIGNALS SIGNALS TRANSFERRED ACROSS TM TO MAXUM IMPLANT WHICH CAUSES OSSICLES TO VIBRATE http://www.ototronix.com/  MAXUM PROCESS/CANDIDACY STEP 1: CANDIDACY STEP 2: DEEP EAR IMPRESSION ≥ 18 YEARS OF AGE PERITYMPANIC IMPRESSION MODERATE TO SEVERE SNHL TOPICAL ANESTHETIC (OPTIONAL) WRS ABILITY ≥ 60% REQUIRES CANAL LUBRICATION PRIOR HA EXPERIENCE USED TO DESIGN IPC & COIL ALIGNMENT EVALUATION UNDER INSERTS COMPREHENSIVE AUDIOGRAM WRS AT MAX AUDIBILITY IN SOUNDFIELD AIDED GAIN W/ HAS AIDED WR AT 50 DBHL SURVEY AMPLIFICATION EXPERIENCE MAXUM PROCESS STEP 3: SURGERY OUTPATIENT PROCEDURE PROCEDURE IS REVERSIBLE IMPLANT TURNED ON IN ~3 WEEKS STEP 4: ACTIVATION MAXGRAM PROGRAM IPC MEASURE FUNCTIONAL GAIN STEP 5: FOLLOW-UP FINE-TUNING MEASURE FUNCTIONAL GAIN TEST WORD RECOGNITION @ 50 DB HL http://www.ototronix.com/  OTOTRONIX MAXUM: BENEFITS McCraney & Glasscock. (2015). Bridging the Gap Between Hearing Aids and Cochlear Implants: Middle Ear  MAXUM: OUTCOMES Word Recognition Open Fit IPC NU-6 Words @ 50 dB 60 88 52 weeks Aided Gain (dB) 50 86 40 84 % correct 20 weeks 30 82 20 80 10 78 0 76 74 72 HA MAXUM Frequency (Hz) McCraney & Glasscock. (2015). Bridging the Gap Between Hearing Aids and Cochlear Implants: Middle Ear  CASE STUDIES McCraney & Glasscock. (2015). Bridging the Gap Between Hearing Aids and Cochlear Implants: Middle Ear VIBRANT SOUNDBRIDGE DEVICE http://thehealthscience.com/thsattachs/  VIBRANT SOUNDBRIDGE TRADITIONAL AMPLIFICATION ISSUES: OCCLUSION, INSERTION LOSS, FEEDBACK DIRECT DRIVE: MECHANICAL ENERGY DELIVERED DIRECTLY TO OSSICLES ENHANCES NATURAL VIBRATORY MOTION ELIMINATES MANY ACOUSTIC ISSUES INHERENT IN TRADITIONAL AMPLIFICATION Avitabile, KM. Vibrant Soundbridge® Implantable Hearing System.  VIBRANT SOUNDBRIDGE VORP FMT Avitabile, KM. Vibrant Soundbridge® Implantable Hearing  VIBRANT SOUNDBRIDGE Samba SEMI-IMPLANTABLE DEVICE Audio Receiver Proces (VORP) EXTERNAL AUDIO PROCESSOR & AMPLIFIER sor (SAMBA2) INTERNAL VIBRATING OSSICULAR PROSTHESIS (VORP) Conductor Lead SOUND PASSES INTO SOUND PROCESSOR AND TRANSMITTED THRU SKIN TO IMPLANTED RECEIVER ON VORP VORP CONDUCTS SOUND TO FLOATING MASS TRANSDUCER (FMT) CAUSING INCUS TO VIBRATE Floating Mass Transducer Avitabile, KM. Vibrant Soundbridge® Implantable Hearing (FMT) System.  VIBRANT SOUNDBRIDGE SURGERY SIMILAR TO COCHLEAR IMPLANTS SMALL INCISION OUTPATIENT PROCEDURE; 1.5 - 2 HOURS PROCESSOR FIT AFTER ~8 WEEKS SAMBA2 AUDIO PROCESSOR MICROPHONE & DIGITAL SIGNAL PROCESSOR 1 X 675 ZINC AIR BATTERY FOR 8-10 DAY USE 2.5 CM DIAMETER ADJUSTABLE MAGNET AVAILABLE IN MULTIPLE COLORS http://www.medel.com/us/the-fmt-of-the-vibrant-soundbridge/ VIBRANT SOUNDBRIDGE CANDICACY CONTRAINDICATIONS ADULTS, BILATERAL MODERATE TO SEVERE CONDUCTIVE/MIXED HL SNHL PROGRESSIVE/SUDDEN HL 55DB MAX LOSS AT 500 HZ ACTIVE OTITIS MEDIA WORD RECOGNITION ≥ 50% TM PERFORATION ASSOC W/ RECURRENT OME WITH HAS AT 65DB SPL RETROCOCHLEAR OR CENTRAL AUDITORY UNAIDED AT MCL DISORDER SKIN CONDITION THAT PRECLUDES USE OF NORMAL MIDDLE EAR ANATOMY SAMBA2 REALISTIC EXPECTATIONS UNREALISTIC EXPECTATIONS  A disadvantage of this device is the confined space of the middle ear restricts the dimensions & crucial mass of the transducer, VIBRANT SOUNDBRIDGE: AUDIOLOGIC INVOLVEMENT AUDIO PROCESSOR ACTIVATION PRE-OPERATIVE SAMBA2 AUDIO PROCESSOR FIT ~8 WEEKS POST-SURGERY COMPREHENSIVE AUDIOGRAM VIBROGRAM FEATURE IN SOFTWARE FOR INCLUDING SPEECH RECOGNITION FINE TUNING POST-OPERATIVE POST-ACTIVATION UNAIDED THRESHOLDS TYPICALLY THRESHOLDS MEASURED AT TIME OF ENT POST- AIDED SPEECH PERCEPTION (W/ CONTRA OP VISIT EAR PLUGGED/MASKED) FOLLOW-UP PROGRAMMING IF NEEDED VIBRANT SOUNDBRIDGE BENEFITS HIGH FREQ GAIN WITHOUT FEEDBACK NO INSERTION LOSS BC THERE IS NOTHING IN YOUR EAR CANAL ELIMINATION OF OCCLUSION EFFECT BC THERE IS NOTHING IN YOUR EAR CANAL IMPROVED COMFORT & EASE OF USE DISTORTION-FREE SIGNAL MORE NATURAL SOUND QUALITY TAKES ADVANTAGE OF LOW FREQ RESIDUAL HEARING FMT IS DESIGNED TO BE LINEAR  VIBRANT SOUNDBRIDGE Overall Sound 18% 56% Quality 89% Overall Fit & Comfort 98% 31% Sound Clarity 86% Cleaning & 54% Maintenance 98% Naturalness of 27% Speech 86% 8% Sound Quality of 24% Background Noise Own Speech 67% 83% 0% 50% 100% HA0% 20% 40% 60% 80% 00% HA 1 Vibrant Soundbridge Vibrant Soundbridge Avitabile, KM. Vibrant Soundbridge® Implantable Hearing  IMPLANTABLE HEARING AIDS: SUMMARY BENEFIT OVER CONVENTIONAL HEARING AIDS SOUND FIDELITY MINIMAL BENEFIT MAINLY COSMETIC CHALLENGES BATTERY (RECHARGING, LIFE-TIME) SIZE-RELATED ISSUES TO DELIVER ENOUGH ENERGY TO INNER EAR PERCEIVED BENEFIT COSTS SURGICAL ISSUES QUANTIFYING BENEFIT BONE CONDUCTION IMPLANTS BONEBRIDGE IMPLANT SYSTEM OSIA SYSTEM Osia 2 Sound Processor Osia® OSI300 Implant  AUDITORY BRAINSTEM IMPLANTS Backous, D. (2011). Opportunities with Implantable Hearing Technologies. SNI Grand Rounds. COCHLEAR IMPLANTS ARE NOT FOR EVERYONE…  Surgically implanted central neural auditory prosthesis for treatment of profound SNHL in children & adults who are not CI AUDITORY candidates BRAINSTEM Device consists of multielectrode surface IMPLANT (ABI) array placed w/in lateral recess of the 4th ventricle along brainstem and directly stimulates the cochlear nucleus  AUDITORY BRAINSTEM IMPLANTS ORIGINAL INTENDED USE: NEUROFIBROMATOSIS TYPE 2 (NF2) DESIGNED TO BYPASS COCHLEA AND VIIITH NERVE NOW ALSO AN OPTION FOR DEAF CHILDREN WITH NO VIII NERVE OR COCHLEAR NERVE THAT COULD NOT BENEFIT FROM A CI  MAIN DIFFERENCES: ABI VS CI PATIENT DISEASE THAT MAY BE LIFE THREATENING PRECISE PLACEMENT OF THE ARRAY MORE DIFFICULT SIDE EFFECTS DURING ACTIVATION EXPECTED LIKE HEART PROBLEMS SURFACE TONOTOPICITY OF THE CN IS NOT PREDICTABLE NOT AS STRAIGHT FORWARD AS IN THE COCHLEA. SO FREQUENCY ALLOCATION IS NOT AS PRECISE OUTCOMES GENERALLY POORER FOR EXAMPLE IN YOUNGER POPULATION cochlear.com MAIN DIFFERENCES: ABI VS CI Diagram showing relative positions of cochlear implant (CI) and auditory Medial geniculate body brainstem implant (ABI) Inferior Colliculus Lateral Lemniscus Superior Olivary Complex Cochlear Nucleus tumor VIIIth Nerve Cochlea http://ieeexplore.ieee.org/ieee_pilot/articles/96jproc07/96jproc07-fayad/article.html AUDITORY BRAINSTEM IMPLANT cochlear.com AUDITORY BRAINSTEM IMPLANTS IMPLANTED IN LATERAL RECESS OF THE 4TH VENTRICLE, ADJACENT TO COCHLEAR NUCLEUS  AUDITORY BRAINSTEM IMPLANTS MICROPHONE PICKS UP SOUND AND SENDS IT TO SIGNAL PROCESSOR PROCESSOR ENCODES SOUND AND SENDS IT TO TRANSMITTER , WHICH SENDS THE SIGNAL TO RECEIVER/STIMULATOR THE SIGNAL IS SENT BY RECEIVER/STIMULATOR DIRECTLY TO THE ABI ELECTRODE ARRAY Davis et al (1997). Cochlear and Auditory Brainstem Implants in the Management of Acoustic Neuroma and Bilateral Acoustic  AUDITORY BRAINSTEM IMPLANTS 8 ELECTRODE IMPLANT DEVELOPED BY COCHLEAR LIMITED, HOUSE EAR INSTITUTE AND HUNTINGTON MEDICAL RESEARCH INSTITUTE (1992) 21 ELECTRODE ARRAY DEVELOPED FOR EUROPEAN MARKET AT SAME TIME BOTH IMPLANTS USED NUCLEUS 22 ABI EXTERNAL SPEECH PROCESSORS 21 ELECTRODE ARRAY IMPLANT USED WITH NUCLEUS 24 ABI SPEECH PROCESSOR (1999) 12 ELECTRODE ARRAY IMPLANT WITH A SPEECH PROCESSOR BASED ON THE C40+ COCHLEAR IMPLANT (MED-EL) 16 ELECTRODE ARRAY IMPLANT WITH THE CLARION-1.2 COCHLEAR IMPLANT (ADVANCED BIONICS) ALSO DEVELOPED INDICATIONS NF2 ≥12 YEARS OF AGE IMPLANTATION MAY OCCUR DURING TUMOR REMOVAL MEDICALLY & SURGICALLY SUITABLE CHILDREN 18 MOS – 5 YRS CONGENITAL VIII NERVE APLASIA AND/OR COCHLEAR APLASIA BILATERAL PROFOUND SNHL STRONG FAMILY SUPPORT cochlear.com  CANDIDACY IN EUROPE Auditory nerve aplasia Auditory nerve hypoplasia Includes Receive no both 12 months & benefit from congenital Head trauma older CI & acquired etiologies: Non-NF2 tumor Severe cochlear ossification  Disorder characterized by growth of noncancerous tumors throughout nervous system Most common tumors are vestibular schwannomas/ acoustic neuromas NEUROFIBROM ATOSIS TYPE 2 Signs commonly appear during adolescence / early adulthood (NF2) In most cases, tumors occur bilaterally by age 30 Incidence 1 in 33,000 people worldwide  SURGICAL APPROACHES Translabyrinthine Mastoid bone removed behind auricle & SCC Provides best visualization of lateral recess of 4 th ventricle Retrosigmoid Less invasive Incision behind auricle Brainstem & cerebellum are assessed thru keyhole opening made near base of skull ABI SURGERY cochlear.co EABR: CN STIMULATION  AUDITORY BRAINSTEM IMPLANTS: COMPLICATIONS STIMULATION OF FACIAL & GLOSSOPHARYNGEAL NERVES (TONGUE AND FACE) NON-AUDITORY SENSATION FOR SOME PEOPLE, THERE ARE NO GUARANTEES INITIAL STIMULATION ALWAYS ADMINISTERED WITH EMERGENCY MEDICAL ASSISTANCE READILY AVAILABLE MANAGEMENT Recipients seen 4-8 weeks post surgery for activation Be careful of eliciting non-auditory side effects Measure upper stimulation levels at all electrodes Complete Pitch Scaling Loudness Balance across all electrodes  AUDIOLOGICAL CONSIDERATIONS PROGRAMMED USING COMBINATION OF MONOPOLAR & BIPOLAR STIMULATION THRESHOLDS MEASURED IN ASCENDING METHOD STARTING AT LEVELS BELOW PERCEPTION COMFORT LEVELS DETERMINED BY RAISING CURRENT LEVEL FROM Θ TO PERCEIVED UNCOMFORTABLE LOUDNESS, TACTILE STIMULATION, DYSGEUSIA, OR DIZZINESS USE ECAPS, EABRS, AND ESRTS TYPICALLY, LONGER PULSE DURATIONS TO PRODUCE RESPONSES WITHOUT NON-AUDITORY SIDE EFFECTS  NON-AUDITORY SIDE EFFECTS UNCOMFORTABLE SENSATIONS ANYWHERE IN BODY TASTE OR OTHER DISTRESS, DIZZINESS, COUGHING, GAGGING OR PROGRAMMING OTHER REFLEXES OFTEN SUBSIDE IN TIME IN ADULTS, SHOULD BE ABI AVOIDED IN CHILDREN MAY NOT USE ALL ELECTRODES IN MAP AT LEAST INITIALLY ASSESS PROGRESS IN TERMS OF AWARENESS, DISCRIMINATION, & IDENTIFICATION OF SOUNDS AND SPEECH  OUTCOMES ABI RECIPIENTS SHOULD EXPERIENCE: DETECTION OF MEDIUM TO LOUD ENVIRONMENTAL SOUNDS AT COMFORTABLE LISTENING LEVELS AT MINIMUM= DETECTION OF SOUND DETECTION OF CONVERSATIONAL SPEECH AT COMFORTABLE LISTENING LEVELS >80% OF ABI RECIPIENTS ARE ABLE TO PERCEIVE SOUND AND USE THE DEVICE POSTOPERATIVELY NOT EVERYONE GETS SOUND OUT OF AN ABI THEY MIGHT JUST GET DETECTION AND DO NOT GET OPEN SET LANGUAGE >80% OF RECIPIENTS DEMONSTRATED STATISTICALLY SIGNIFICANT IMPROVEMENTS IN OPEN-SET SENTENCE UNDERSTANDING AUDITORY BRAINSTEM IMPLANTS PROVIDES ENOUGH AUDITORY INFORMATION TO IMPROVE LIP- READING ABILITIES A FEW PATIENTS ARE ABLE TO ACHIEVE OPEN-SET SPEECH UNDERSTANDING VARYING SUCCESS IN PATIENTS BORN WITH COCHLEAR NERVE APLASIA UNC Healthcare  TEN-YEAR FOLLOW-UP OF ABIS Veronese S, Cambiaghi M, Tommasi N, Sbarbati A, Galvin JJ, III (2023) Ten-year follow-up of auditory brainstem implants: From intraoperative electrical auditory brainstem responses to perceptual results. PLoS ONE 18(3): e0282261. https://doi.org/10.1371/journal.pone.0282261 LEVELS OF AUDITORY PERFORMANCE LEVEL 0: NO SOUND AWARENESS OF SOUNDS & WORDS, 65 DBA LEVEL 1: ≥60% CORRECT DETECTION OF SOUNDS & WORDS, 65 DBA THEY CAN JUST DETECT A SOUND BEING PRESENT LEVEL 2: ≥60% CLOSED-SET DISYLLABIC WORD IDENTIFICATION CLOSED-SET IDENTIFICATION LEVEL 3: ≥60% OPEN-SET WORD & SENTENCE RECOGNITION ABI OUTCOMES IN CHILDREN Colletti et al. (2014) Audiol Neuroto CATEGORIES OF AUDITORY PERFORMANCE (CAP) 0. NO AWARENESS OF ENVIRONMENTAL SOUNDS OR VOICE 1. AWARENESS OF ENVIRONMENTAL SOUNDS 2. RESPONSE TO SPEECH SOUNDS 3. IDENTIFICATION OF ENVIRONMENTAL SOUNDS 4. DISCRIMINATION OF SPEECH SOUNDS WITHOUT LIPREADING 5. UNDERSTANDING OF COMMON PHRASES WITHOUT LIPREADING 6. UNDERSTANDING OF CONVERSATION WITHOUT LIPREADING 7. USE OF A TELEPHONE WITH KNOWN SPEAKER 8. FOLLOWS GROUP CONVERSATION IN A REVERBERANT ROOM OR WHERE THERE IS SOME INTERFERING NOISE, SUCH AS A CLASSROOM OR RESTAURANT 9. USE OF TELEPHONE WITH AN UNKNOWN SPEAKER IN UNPREDICTABLE CONTEXT OTHER IMPLANTABLE OPTIONS PENETRATING AUDITORY BRAINSTEM IMPLANT (PABI) PENETRATES COCHLEAR NUCLEUS  PABI  DESIGNED TO IMPROVE ABI FUNCTION  MODIFIED VERSION OF EXISTING ABI  HYBRID IMPLANT CONSISTING OF MICROELECTRODES AND STANDARD SURFACE ELECTRODES  ELECTRODES OF VARYING LENGTHS TO TAKE ADVANTAGE OF TONOTOPIC ORGANIZATION OF CN  PENETRATE DEEP (1–2 MM) TO STIMULATE NEURAL PATHWAYS INACCESSIBLE AT CN SURFACE  PRODUCE LOCALIZED STIMULATION OF CN AND SEND SOUND SIGNALS TO THE BRAIN  PABI TRIAL (OTTO ET AL., 2008) 10 INDIVIDUALS WITH NF2 60% OF SURFACE ELECTRODES WERE EFFECTIVE Consona Vowels CUNY CUNY CUNY nts (aud) (aud) (vis) (aud + (aud) vis) PABI 25.8 2.6 29.0 61.6 20.6 (7.4) (n=5) (13.8) (3.3) (14.7) (27.4) ABI 26.8 36.8 7.6 30.6 64.7 (n=92 (15.6) (16.3) (12.2) (16.8) (22.4) ) p 0.072 0.076 0.012 0.260 0.408 value  AUDITORY MIDBRAIN IMPLANT (AMI) STIMULATES INFERIOR COLLICULUS CN MAY BE DAMAGED LIMITING ABI PERFORMANCE INITIAL CANDIDATES NF2 PATIENTS AUDITORY MIDBRAIN IMPLANT (AMI)  AUDITORY MIDBRAIN IMPLANT (AMI) LIM ET AL 2008: 3 NF2 PATIENTS SAFE FOR HUMAN USE PROVIDES HEARING PERFORMANCE COMPARABLE TO NF2 ABI PATIENTS PERFORMANCE VARIES DRAMATICALLY DEPENDING ON IMPLANT LOCATION W/IN MIDBRAIN BEST PERFORMER STILL NOT ABLE TO ACHIEVE OPEN SET SPEECH PERCEPTION WITHOUT LIP- READING COMPLETELY IMPLANTABLE COCHLEAR IMPLANTS LEVERAGES MEI TECHNOLOGY PRIMARY CHALLENGE: IMPLANTABLE MICROPHONE ESTEEM ACCLAIM FULLY IMPLANTABLE COCHLEAR IMPLANT (FICI) FDA IN 2020 SAID THAT THEY COULD GO TO CLINICAL TRIALS MED-EL MI2000 TOTALLY IMPLANTABLE COCHLEAR IMPLANT (TICI) ARTIFICIAL BASILAR MEMBRANE (ABM)