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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
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Conductive
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Sensorineural
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Combined conductive and sensorineural
Central
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Inner ear sensory cells or auditory nerve fiber are dysfunctional
Mixed
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Sound waves are not able to stimulate the sensory cells of the inner ear
Affects auditory areas of brainstem and temporal lobe
Functional
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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
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Ototoxic medications
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Damage to middle ear structures
Old age
Diseases
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Gradual or sudden
Physical trauma
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Damage sensory cells in inner ear
Loud noise
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Otosclerosis; autoimmune inner ear disease
Meningitis
Tumor
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Vestibulocochlear nerve
Types of Hearing Devices
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Hearing aid

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5 different types
Amplifies and modulates sound waves
Cochlear implants

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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
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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
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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
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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:
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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 $
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The SoundBite costs $6,800 and is available in a pilot
launch at 42 major hearing centers in the US
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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?

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Dental guidelines?

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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?
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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?
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Yes, it will not interfere
Advisable to clean device after eating
In summary…
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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.