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

Sound waves are not able to stimulate the sensory cells of the inner ear Sensorineural

Inner ear sensory cells or auditory nerve fiber are dysfunctional Mixed

Combined conductive and sensorineural Central

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

Otosclerosis; autoimmune inner ear disease

Ototoxic medications Damage sensory cells in inner ear

Loud noise Gradual or sudden

Physical trauma Damage to middle ear structures

Old age Diseases

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 waves2) Digital signal processor processes the sound3) Wireless chip transmits to the ITM4) 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 Process1) 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? 18+ years, with SSD and/or conductive hearing loss and

good oral health 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? 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 CitedAshitani, 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/Ototoxic-Medications/.

“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.