a breakthrough hearing technology

a removable, discreet, non-invasive bone conduction
hearing solution via the teeth, clinically proven more
effective than surgical implanted devices1,2

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ABOUT THE
TECHNOLOGY

There are over 10 million patients in the US with Single-Sided Deafness (SSD) or certain types of Conductive Hearing Loss (CHL) who are candidates for a bone conduction hearing device. They seek a non-invasive, removable and non surgical solution which is more discreet and more affordable and with better audiological efficacy, safety, and benefit than a surgical device.

SoundBite is a breakthrough technology for SSD and CHL

SoundBite is the world's FIRST non-surgical and removable hearing solution that imperceptibly transmits sound via the teeth as bone conduction, helping patients who suffer from SSD or CHL rejoin the conversation of life. It is the ONLY non-invasive Direct-Drive Bone Conduction solution in the world which transmits sound without skin and soft tissue interference because it uses the teeth as a“naturally osseointegrated”post and eliminates the need for surgery.

- From the ground up, original innovation with over 130 patents covering 22 countries.

- Cleared by FDA (US), CE (Europe) and NMPA (China).

- #1 in“Top 10 Medical Innovations 2010”by Cleveland Clinic.

SoundBite is the only non-invasive Direct-Drive Bone Conduction solution in the world as it uses the teeth as a“naturally osseointegrated”post.

SoundBite is ideal for SSD and CHL

Clinically proven more effective than surgical implanted devices

Patients with SoundBite hear crisp and natural sound. Without skin and soft tissue attenuation, lossless transmission of sound is made via the teeth, which are anatomically embedded into the skull sending sound to both cochlea, similar to a surgical osseointegrated post. Placing the microphone in the ear canal allows SoundBite to capitalize on the natural acoustic benefit provided by the patient’s own pinna, or outer ear, to capture and direct sound in the environment.

- Much better high-frequency performance, crucial to SSD patients, than all surgically implanted Bone-Anchored Hearing Instruments (BAHI) devices thanks to the proprietary piezoelectric transducer 1.

- Superior auditory performance to surgical implanted solutions: 10 dB better sound field thresholds; better APHAB Scores and equivalent sound localization abilities and speech perception-in-noise performance 2.

SoundBite is the SoundBite has superior performance to surgical implanted BAHI devices in a frequency range critical to spatial hearing and speech perception in noise1.

Patients with SoundBite has 10dB better sound field thresholds than surgical implanted BAHI2.

Clinically proven satisfaction and safety 2-11

- 94-100% SoundBite patients would likely recommend 7,9,10.

- High APHAB Scores.

- No initial or ongoing surgical complications.

- Safe to teeth and gum. No dental changes needed.

More discreet, comfortable and affordable

- Apply or remove easily in seconds.

- Virtually invisible when worn.

- Comfortable thanks to the dental customization.

- Much more affordable than surgical solutions.

- No hassle for usual eating and drinking.

Apply or remove easily in seconds; virtually invisible when worn; comfortable thanks to the dental customization.

- advanced noise cancelling
- auto acoustic adaptation to environment
- up to 32 hours total battery time*
- iPhone/Android App
- remote fitting
*The included portable charger/battery module provides additional 3 cycle
charges making the total battery time up to 32 hours.

THE PRODUCT DETAILS

SoundBite Hearing System

The SoundBite Hearing System has two principal modules: the microphone module, typically a miniature behind-the-ear (BTE) unit with a microphone located in the ear canal of the impaired ear and the transducer module, a removable, invisible custom-made in-the-mouth (ITM) device worn on the upper, left or right, back teeth. Both modules have a rechargeable battery.

Each of the modules will operate about 8 hours after a full charge. The included portable charger/battery module provides an additional 3 cycle charges making the total battery time up to 32 hours.

The microphone module is also provided in several alternative forms, such a clip-to-collar microphone, or microphone built in an earring, necklace, barrette. These alternative modules provide extremely flexible and invisible ways of wearing and are ideal for the patients with congenital microtia, with chronically draining ears or who simply want to be seen wearing nothing on the ear.

THE PRODUCT DETAILS

How SoundBite Works

- The microphone module captures and processes sound and wirelessly transmits the processed sound signal to the ITM.

- The ITM receives this signal and applies it as sound vibrations to the teeth with a proprietary piezoelectric transducer.

- These subtle sound vibrations travel via the teeth to the skull as bone conduction to the functioning inner ear, or cochlea, bypassing the outer or middle ear entirely. The subtle vibrations are not felt on the teeth but are strong enough to be picked up by the cochlea.

Shanghai

The hub of world class
innovation and manufacture

Sonitus Medical Shanghai R&D and Manufacture Center

SONITUS MEDICAL SHANGHAI (SMS)

The SoundBite technology was originally developed by Sonitus Medical, San Mateo, CA. The high manufacture cost made the commercialization of the innovative product very challenging in the US hearing market, in which most of the non-surgical hearing devices were not reimbursed. To make the proven technology of benefit to patients across the world, the technology and intellectual property was acquired by Sonitus Medical Shanghai (SMS), whose R&D and manufacture center is located in Shanghai International Medical Park. By leveraging the powers of new engineering innovation, supply chain & manufacturing, SMS is bringing a better, much improved and more affordable SoundBite back to the market.

SMS is currently looking for strategic business partners who can help to market SoundBite, the innovative and unique product, to the global markets.

Contact info:

bd@sonitus.com

PUBLICATIONS ON SOUNDBITE

1. Syms, M.J., Hernandez, K.E., Otology and Neurotology, Bone Conduction Hearing: Device Auditory Capability to Aid in Device Selection.

2. Moore, Brian C.J., Popelka, Gerald R., International Journal of Audiology, Preliminary comparison of bone-anchored hearing instruments and a dental device as treatments for unilateral hearing loss.

3. Popelka, Gerald et. al., Otology & Neurotology, Preliminary Evaluation of a Novel Bone-Conduction Device for Single-Sided Deafness.

4. Miller, Ross, American Journal of Orthodontics and Dental Facial Orthopedics, It’s time to listen to our teeth; the SoundBite Hearing System.

5. Popelka, Gerald et. al., Chapter in a special issue of Seminars in Hearing on Single Sided Deafness, SoundBite Hearing System by Sonitus Medical.

6. Murray, M., Popelka, G., Miller, R., Otology & Neurotology, Efficacy and Safety of an In The Mouth Bone Conduction Device for SSD.

7. Murray, M., Miller, R., Hujoel, P., Popelka, G., Otology & Neurotology, Long Term Safety and Benefit of a New Intraoral Device for Single Sided Deafness.

8. Miller, R., Murray, M., Popelka, G., Journal of Clinical Dentistry, Safety of an Intra-Oral Hearing Device Utilizing a Split Mouth Research Design.

9. Gurgel, R.K., Shelton, C., The Laryngoscope, The SoundBite Hearing System, Patient-Assessed Safety and Benefit Study.

10. Gurgel, R.K., Shelton, C., Otology & Neurotology, A Novel, Intraoral Bone Conduction Hearing Prosthesis: One year Safety and Efficacy Study.

11. Qiong Luo, et al. Neural Plasticity Volume 2020, Effects of SoundBite Bone Conduction Hearing Aids on Speech Recognition and Quality of Life in Patients with Single-Sided Deafness.

12. Xi Xin, et al. Chin J Otolaryngology Head Neck Surg, 2021, 56(5): 478-486. Preliminary audiological evaluation of the SoundBite bone conduction devices in adults with single-sided deafness.