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International Hearing Society 61st Annual IHS Convention and Expo Alternative Hearing Technology September 22, 2012 Mark J. Syms, MD, FACS Arizona Ear Center Phoenix, AZ www.arizonaear.com Background • • • • • Married with 3 children Born and raised in Philadelphia Attended Boston College Jefferson Medical College Otolaryngology Residency at Tripler Medical Center in Honolulu • Otology/Neurotology Fellowship at House Ear Clinic in Los Angeles Arizona Ear Center www.arizonaear.com • Central Phoenix Location • Tertiary referral practice – patients from entire state and adjacent areas • Disorders of the Ear – the “E” of ENT • Ear Disorders – Cholesteatoma, Tympanic Membrane Perforations, Cochlear Implants, Hearing Loss, Hearing Aids, Implantable Hearing Devices, Acoustic Neuromas • Facial Nerve Disorders • Balance Disorders Anatomy Expectations of IMEHD • Enhanced, natural sound quality, especially in noise • Reduced feedback and maintenance issues • Improved fit, comfort, and cosmetics • Elimination of ear canal occlusion • Safe surgery that does not adversely affect anatomy or physiology of the ear Implantable Middle Ear Hearing Devices What are the benefits? • No occlusion • No feedback • Better speech understanding in the presence of background noise • More comfortable • Natural sound Implantable Middle Ear Hearing Devices What are the risks? Surgery-related risks (partial list) • Anesthesia effects • Additional hearing loss • Taste disturbance Non-surgical risks • Unknown long-term effects Implantable Middle Ear Hearing Devices How do they work? • Sends sound energy from outside the head to the bones in the middle ear • Bypasses the ear canal and eardrum (except Soundtec DDHS) Implantable Middle Ear Hearing Devices Transducer Types • Electromagnetic – Electromagnetic fields, when surrounding a permanent magnet, interacts with the magnet causing it to move (attract and repel). • Piezoelectric – Electrical energy can be applied to a ceramic material, causing it to alter its volume Envoy Esteem Envoy Maxim Hearing Implant Maxim Hearing Implant Nd2Fe14B Magnet (Neodymium Iron Boron) Laser Welded Titanium Cylinder (1.5 mm x 3.5 mm) Residual Hearing-Loading Effect Avg. Change by Air = 4.2dB Avg. Bone change = 1.1dB Frequency in Hz .25K .5K d B H L 0 10 20 30 40 50 60 70 80 90 100 1K 2 3K 4K 6K PreImplant PostImplant Maxim In-the-Canal Processor Med-El Vibrant Soundbridge • Electromagnetic transducer • Single point attachment • Semi-implantable with upgradable technology Symphonix® Vibrant® Soundbridge™ Vibrating Ossicular Prosthesis™ ™ (VORP ) Receives signal from external Audio Processor™ (AP) Transmits signal to Floating Mass Transducer™ (FMT™) Floating Mass Transducer™ • Single point attachment • Small size – 2 mm length by 1.5 mm diameter – 25 mg Med-El Vibrant Soundbridg • The FMT™ should be in contact with the incudostapedial joint and parallel to the axis of motion of the stapes • Round Window Placement Bone Conduction Hearing (not only the BAHA) Aural Atresia • IF a patient is a candidate, canaloplasty • 30-50% revision • 25-30 dB air bone gap GOOD result Bone Conduction Aid • Uncomfortable • Poor Cosmesis • Diminished gain and fidelity secondary to skin, muscle and fat Osseointegration Traditional alternatives Direct Bone Conduction • Works independently of ear canal and middle ear • Direct transmission gives clear sound • Preoperative testing possible • High wearing comfort • Safe and simple surgery The Baha System The ® BAHA System Cochlear™Baha® Product Portfolio Cochlear™ Baha 3 (BP100) Baha 3 Power (BP110) Baha Cordelle II Top performance, fully automatic, head-worn, All-round device Head-worn power, Discreet device Client need: Super power, body-worn Ponto Bone Anchored System Sound Processors Standard features Hole for safety line Push button: •Program selection •Stand-by/Mute Coupling Inlet for programming Battery door Volume Direct Audio Input connector control Microphones Hearing Aids are Medically Inappropriate for SSD & Some CHL Inner Ear Middle Ear Outer Ear Conductive Hearing Loss One cochlea is completely impaired = Single Sided Deafness (SSD) SSD Cochlear has normal function but Middle and/or Outer ear problem CHL Hearing Loss Indications Single Sided Deafness • Caused by: –Acoustic neuroma tumors, other surgical intervention –Sudden deafness –Neurological degenerative disease –Trauma –Ototoxic treatments –Genetics –Meniere’s Disease Baha System Candidate Single Sided Deafness • > 5years of age. • Normal hearing in contralateral ear. – Normal hearing is defined as PTA AC threshold equal to or better than 20 dB at .5, 1, 2 and 3kHz. • Functions by transcranial routing of the signal. The Baha System for SSD Clinical Aspects Single Sided Deafness • For adults: – Difficulty understanding in group conversations, or with noise. – Difficulty localizing sounds. – Difficulty understanding a person situated on the deaf side. • For children: – Same difficulties as adults. – School handicap. Initial findings Single Sided Deafness • Handicap of SSD was UNDERESTIMATED. • Complaints of SSD: – Difficulty understanding speech in noise – Difficulty hearing sounds presented on the deaf side – Unbalanced environment Personal Hygiene Simply clean around the abutment with a soft cleaning brush and gentle soap. This type of cleaning should take place at minimum 2 to 3 times weekly after the area is healed from surgery. SoundBite SoundBite Prosthetic Device For Treating Single Sided Deafness & Conductive Hearing Loss • Non-surgical bone conduction prosthetic device that transmits sound via the teeth • FDA cleared as a prosthetic device for Treatment of SSD & CHL • Lower cost, lower complication alternative to prevalent surgical treatment that uses same mechanism of action (bone conduction) SoundBite Eliminates Surgical Costs and Complications by Using the Tooth as a “Naturally Osseointegrated” Post Baha® SoundBite™ Transducer Post = Tooth Bone Cochlea • Simple, non-surgical, non-invasive, and removable • Superior sound quality: • Much wider frequency response (500 to 12K Hz ) than existing hearing devices, • Microphone location in ear canal takes advantage of natural acoustics • Nearly invisible as worn • Overall treatment cost is lower • No surgical facility fee, anesthesiology fee, or post-op care expenses Cochlear Implants Hearing Aids • Presbycusis most common cause of sensorineural hearing loss • Hearing aids are and will remain the best options for MOST patients • Hearing aids restore volume Hearing Aids • Hearing aids in patients with poor understanding often lead to patient dissatisfaction • Hearing aids unable to rehabilitate understanding problems • Understanding problems worse in noise Technology • Fit the best technology to best rehabilitate the loss • Multiple factors involved in determining what is best for a patient Candidacy There are four main areas of cochlear implant candidacy to meet and complete. • Audiologic candidacy • Medical candidacy • Psycho/social candidacy • Insurance authorization Audiologic Criteria Pediatric Selection Criteria Typical Hearing Loss Profile - Severe-to-profound hearing loss in both ears - Limited benefit from hearing aids - In children, plateau in auditory development with appropriate intervention Older Children/ Adult Selection Criteria – Moderate-to-profound hearing loss in the low pitches and severe-to-profound hearing loss in the mid-to-high speech pitches – Can “hear” with hearing aids but cannot “understand” what is said - Reliance on lipreading or sign language - Cannot use the telephone without difficulty - Speech testing in best aided condition is less than 50% Wheel of Fortune _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ _____ With only vowel sounds, it is difficult to make out the words _____ O _____ _____ _____ E A _____ I _____ _____ _____ A _____ _____ With consonants only, it is much easier C _____ C H L _____ _____ R _____ M P L _____ N T However, you must first be able to detect both vowels and consonants in order to discriminate speech C O CHL E A R I M P L A N T Hearing aids are unable to provide access to both vowel and consonant sounds due to acoustic feedback, and limit in high pitch gain. Because a cochlear implant utilizes electrical sound energy, more like our body’s natural nerve impulses, there is access to all of the pitches of speech. TWO main aspects to understand with the transition from hearing aids to a cochlear implant • #2 Hearing aids • Cochlear Implants – Provide amplified sound to hair cells in the organ of hearing. Sound will only be as clear as the cochlea itself. – Transmit sounds directly into the cochlea bypassing the distorted hair cells. – “Goes through the hearing loss” – “Goes around the hearing loss” Clarity • Hearing aids are unable to provide a “clearer” signal of speech to your brain due to distortion in the cochlea. • Only a cochlear implant can improve speech clarity and understanding. This does not happen over night, but it does improve, the more a patient uses and practices with the device. (aka all waking hours). Mechanics of the Cochlear Implant External Parts • Microphone The microphones serve to detect sound and filter sound to the processor. External Parts • Processor The processor interprets sound, as programmed during a patient’s mapping and programming session. This dictates the speed at which sound is processed and the manner in which electrical energy will activate the electrodes. External Parts • Cables The cables serve to transmit sound from the processor to the headpiece coil. External Parts • Coil The coil transmits the sound from the external device to the internal hardware. • Magnet The magnet pulls the external and internal hardware together so they may communicate External/Internal Parts • Radio Frequency The communication of sound from the external device to the internal device occurs via radio frequency. assigned to CIs. Internals Parts • Internal hardware The internal hardware sends the programmed electrical energy to the electrodes. Frequency Distribution 2000 Hz 500 Hz ≥4000 Hz Internal Parts • Electrodes The electrodes send electrical pulses to spiral ganglion cells within the cochlear which in turn stimulate the nerve. THREE MANUFACTURERS YOUR CHOICE Arizona Ear Center believes in the patient’s right to choose which device is best for them. Appropriate expectations….. ……….EQUALS SUCCESS Completing the process of a cochlear implant • Evaluation and consultations • Demonstrating understanding of the commitment and desire to hear better • Completion of the evaluation check-list • Insurance authorization • Surgery scheduling Minimally Invasive Incision Implant Well Mastoidectomy Inferior (feet) Superior (top of head) Posterior (table) Left Ear • Ear canal (auricle flipped anteriorly) • Mastoid tip used as initial drilling landmark Facial Recess Superior Inferior (feet) (top of head) Posterior (table) Left Ear • Facial recess is a triangle within a triangle • Facial recess boundaries: – Fossa incudis superiorly (middle ear / incus) – Facial nerve posteriorly (motor innervation to the face) – Chorda tympani nerve anteriorly (a branch of the facial nerve, taste) Facial Recess Left Ear • Visualization of the stapes • Visualization of the facial nerve and chorda tympani Facial Recess Left Ear • Incudostapedial joint • Incus points to the round window • Promontory denotes the external surface of the cochlea Cochleostomy Right Ear Anterior (nose) Superior • The cochleostomy is created anterior and inferior to the round window. (1.5 and 1.0 diamond burrs.) (head) Inferior (feet) Posterior (table) Cochleostomy Electrode Insertion Electrode Insertion Minimally Invasive Cochlear Implantation Minimally Invasive Cochlear Implantation Paradigm Shift • Best care involves DIRECT cooperative care between hearing healthcare provider and otologist • Remove primary care as “middle man” • Elimination of economic competition Hearing Healthcare Providers • Provide the best patient care possible • Highest level of patient satisfaction • Economically viable practice Arizona Ear Center Paradigm Shift • Project most advanced technology to all regions of Arizona • Provide hearing aids and service LOCALLY Arizona Ear Center Paradigm Shift • Local care is the best care • Enhance hearing healthcare provider’s practice with cutting edge technology Arizona Ear Center Paradigm Shift • Provide referral forms to hearing healthcare providers • Arrange for needed referral on behalf of the patient • Correspondence to hearing healthcare providers Arizona Ear Center Paradigm Shift • Refer patients for evaluation – not implantation • If 100% of referred patients receive an implant, you are not sending all of the possible candidates • Patient exploration of technology enhances your practice and reputation Questions?