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Bone Conduction Hearing Aids SoundBite Hearing System How does hearing work? Hearing [heer-ing], noun: the faculty or sense by which sound is perceived Classification of Hearing Loss Conductive Sensorineural Combined conductive and sensorineural Central Inner ear sensory cells or auditory nerve fiber are dysfunctional Mixed Sound waves are not able to stimulate the sensory cells of the inner ear Affects auditory areas of brainstem and temporal lobe Functional No pathological cause (believed to be psychological) 36 million Americans have hearing loss; conductive and sensorineural are the most common types (both can lead to single-sided hearing loss) Causes of Hearing Loss Genetic Ototoxic medications Damage to middle ear structures Old age Diseases Gradual or sudden Physical trauma Damage sensory cells in inner ear Loud noise Otosclerosis; autoimmune inner ear disease Meningitis Tumor Vestibulocochlear nerve Types of Hearing Devices Hearing aid 5 different types Amplifies and modulates sound waves Cochlear implants Electronic device with under-the-skin portion and behind-the-ear portion Electrode array directly stimulates auditory nerve But there are other options… Bone Conduction (BC) Devices Bone conduction carries sound through the bone in the skull Transmits vibrations from hearing aid, through the bone, and to the cochlea Example: ear plugs, chewing Traditional BC hearing aid Bone anchored hearing aid The non-invasive and removable solution to singled-sided deafness and conductive hearing loss using teeth by Sonitus Medical • What is the SoundBite? – ITM (in-the-mouth) device that snaps around the upper back teeth on one side – BTE (behind-the-ear) microphone that is worn on the impaired ear How does it work? 1) BTE microphone picks up sound waves 2) Digital signal processor processes the sound 3) Wireless chip transmits to the ITM 4) ITM converts signals into imperceptible vibrations that travel via the teeth to the cochlea SoundBite in Detail Both the BTE and ITM are powered by rechargeable batteries ITM lasts 6-8 hours BTE lasts 15-18 hours BTE has a broad frequency range (500 Hz – 12 kHz) Teeth do not need to be altered ITM consists of sealed and flat battery, wireless capability, and an actuator The ITM is hermetically sealed in a dental grade acrylic Treatment Process 1) Physician/audiologist visit • Hearing evaluation and prescription 2) Dentist visit • Routine dental screening and impression taken 3) SoundBite Device is custom made by Sonitus Medical • Takes about 2 weeks 4) Audiologist visit • Programming and instructions 5) Replace approx. every 3 years • …or when device stops working No surgery, no dental work, available within a few weeks = a very simple process Clinical Trials - 2011 Multi-center trial using adults ages >18 and <80 with permanent SSD and no current SSD device Wore device for 8.2 hours a day for 30 days Results: Improved ability of patients to understand speech in noise by an average of 25% 1/3 of the patients had improvement exceed 30% Significance: showed that SoundBite is as effective as bone anchored hearing aids Murray, Michael, Gerald R Popelka, and Ross Miller. “Efficacy and Safety of an In-the-mouth Bone Conduction Device for Single-sided Deafness.” Otology & Neurotology: Official Publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology 32, no. 3 (April 2011): 437–443. doi:10.1097/MAO.0b013e3182096b1d. $ Cost $ The SoundBite costs $6,800 and is available in a pilot launch at 42 major hearing centers in the US Sonitus Medical hopes to win Medicare coverage before making it more widely available Is currently covered by some private insurance companies as a prosthetic device In comparison, the bone anchored hearing aid costs approximately $10,000 and is eligible for Medicare reimbursement SoundBite FAQs Who is eligible? Dental guidelines? 2 contiguous molar or premolar teeth with no untreated tooth decay Healthy attachment with pockets no larger than 5mm No mobile teeth (dentures) What are the contraindications for SoundBite? 18+ years, with SSD and/or conductive hearing loss and good oral health Allergies to device components (polymers) Hand handicaps Can a patient eat/drink normally with SoundBite? Yes, it will not interfere Advisable to clean device after eating In summary… No surgery needed (non-invasive) Comfortable and custom-fitted Clinically proven Virtually invisible while worn In the clinical trials, 95% of patients would recommend it to a friend who also had single-sided deafness Questions? Works Cited Ashitani, Michiko, Chiho Ueno, Tadashi Doi, Toshihiko Kinoshita, and Koichi Tomoda. “Clinical Features of Functional Hearing Loss with Inattention Problem in Japanese Children.” International Journal of Pediatric Otorhinolaryngology 75, no. 11 (November 2011): 1431–1435. doi:10.1016/j.ijporl.2011.08.009. “Autoimmune Inner Ear Disease.” Accessed May 3, 2013. http://vestibular.org/autoimmune-inner-ear-disease-aied. Beck, Melinda. “Using Teeth to Help Restore Hearing in One Ear.” Wall Street Journal, July 9, 2012, sec. Health Journal. http://online.wsj.com/article/SB10001424052702303343404577516691819675900.html. “Causes of Hearing Loss in Adults.” Accessed May 3, 2013. http://www.asha.org/public/hearing/disorders/causes_adults.htm. Health, Center for Devices and Radiological. “Hearing Aids - Types of Hearing Aids.” WebContent. Accessed May 3, 2013. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/ HearingAids/ucm181470.htm. Murray, Michael, Gerald R Popelka, and Ross Miller. “Efficacy and Safety of an In-the-mouth Bone Conduction Device for Single-sided Deafness.” Otology & Neurotology: Official Publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology 32, no. 3 (April 2011): 437–443. doi:10.1097/MAO.0b013e3182096b1d. “Ototoxic Medications (Medication Effects).” Accessed May 3, 2013. http://www.asha.org/public/hearing/OtotoxicMedications/. “SoundBiteTM Bone Conduction Hearing System.” Accessed May 3, 2013. http://www.soundbitehearing.com/soundbite/difference.cfm. “SoundBiteTM for Single Sided Deafness - Clinical & Scientific Information.” Accessed May 2, 2013. http://www.soundbitehearing.com/soundbite/scientific-info.cfm. What Is SoundBiteTM?, 2013. http://www.youtube.com/watch?v=ExTSW5Ogat4&feature=youtube_gdata_player.