SoundBite Hearing System

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SoundBite Hearing System is a non-surgical bone conduction prosthetic device that transmits sound via the teeth. It is an alternative to surgical bone conduction prosthetic devices, which require surgical implantation into the skull to conduct sound.

Contents

SoundBite avoids surgery by using the teeth rather than the implanted component. As a result, it is frequently less expensive and less complicated than the common surgical procedures.

SoundBite Hearing System has two principal components: a behind-the-ear (BTE) microphone unit that is worn on the impaired ear and a removable, custom-made in-the-mouth (ITM) device worn on the upper, left or right back teeth. Both components have rechargeable batteries and a charger is included with the system.

The BTE microphone captures and processes sound, wirelessly transmitting signals to the ITM device. The ITM converts these signals into subtle sound vibrations, which travel through the teeth and skull bones to reach the functioning inner ear, bypassing potential outer or middle ear complications. The vibrations are strong enough to be detected by the cochlea but remain imperceptible to the wearer.

In the United States, the device has FDA clearance to treat patients with single-sided deafness (SSD) or conductive hearing loss (CHL). SoundBite also has CE mark approval for SSD, CHL, and mixed hearing loss (MHL).

SoundBite was developed and marketed by Sonitus Medical, Inc. The company filed for bankruptcy on Thursday, January 15, 2015, [1] as a result of the US Centers for Medicare & Medicaid Services' decision not to cover the device. [2]

History

Single-sided deafness (SSD) and conductive hearing loss (CHL) are life-altering conditions where patients often have anxiety, depression, social isolation, and reduced quality of life. [3] [4] SSD patients have one cochlea that is virtually non-functional. It does not hear sound even when using conventional hearing aids, which are amplification devices that simply "turn up the volume" on air-conducted sound. CHL patients have a problem with the ear (outer, middle or canal) that prohibits air conducted sound from reaching an otherwise functional cochlea. Conventional hearing aids which amplify sound can cause distortion for these patients. Therefore, the traditional treatment approach has been a prosthetic device called Baha, which replaces the function of the impaired ear by using a well-established principle called bone conduction to re-route sound through the skull bones to the functional cochlea.

The Baha bone conduction prosthetic devices are used rather than hearing aids because conventional hearing aids are clinically inappropriate for these patients. The Baha surgery can cause complications that range from skin reaction to infection, to abscess, to complete re-implantation or revision of the Baha post. [5]

In the United States, the Medicare Benefit Policy Manual distinguishes between hearing aids and prosthetic devices, and indicates that certain devices (including Baha) are payable by Medicare as prosthetic devices when hearing aids are medically inappropriate. [6]

The principle of bone conduction has been used for many years to treat patients with single-sided deafness and conductive hearing loss. The principle is based on decades of research showing that bone conduction stimulation of the teeth initiates auditory sensations. Evidence shows that teeth vibrations lead to audio-frequency vibration transmissions via soft tissue. Those transmissions then travel through skull foramina into the skull cavity. From there, they channel into the inner ear fluids, stimulating the cochlea. [7] Subsequently, Sonitus Medical developed SoundBite Hearing System to use those principles in a non-surgical, removable hearing system.

Clinical trials

A multi-center clinical trial conducted in 2011 validated that SoundBite is safe and effective and provides substantial benefit for individuals with single-sided deafness (SSD). Trial participants wore SoundBite for 30 days, using the device an average of 8.2 hours per day. Based on the clinical trial results, SoundBite improves the ability of individuals with SSD to understand speech in an environment with background noise by an average of 25%. One-third of the trial participants found that the system improved their hearing ability by more than 30%. The results of this extensive clinical trial showed SoundBite to be as effective as surgically implanted bone conduction systems in improving the ability to understand speech in an environment with background noise. [8]

In 2013, another multi-center clinical study confirmed previous findings that SoundBite is safe, effective, and provides significant benefit for patients. Study participants wore SoundBite for 6 month. Benefit was determined through a standard audiological questionnaire called the Abbreviated Profile of Hearing Aid Benefit (APHAB), and a patient survey. Results from the APHAB questionnaire showed patients had significant improvement in Ease of Communication, Reverberation, Background Noise, and Global Benefit. Additionally, the patient survey showed strong satisfaction with the device: 100% would recommend SoundBite to a friend or family member with similar hearing loss. [9]

Description

Sound vibrations travel through a medium, and sound is heard when sound waves travel through the medium of air or bones/teeth to arrive at the inner ears. The SoundBite Hearing System uses sound waves travelling through bone, known as bone conduction to transmit subtle vibrations through bones to the inner ears.

The SoundBite Hearing System is a non-surgical and removable bone conduction hearing prosthetic device that re-routes sound through the teeth and skull bone directly to the functioning inner ear or cochlea. By-passing problems in the outer and middle ears entirely. For patients with single-sided deafness, SoundBite re-routes sound from the deaf side, to the functioning cochlea, by-passing the non-hearing side.

SoundBite uses the same mechanism of action as Baha devices (bone conduction), however it places a transducer on the tooth a "naturally osseointegrated" postand thereby eliminates the need for a surgical implant.

SoundBite relies on two primary components to deliver sound:

The BTE unit has a 12-to-15-hour operational life when fully charged. [10] Each ITM hearing device has a 6-to-8 hour operational life when fully charged. [10] The SoundBite Hearing System includes 1 BTE, 2 ITMs, and a system charger.

The BTE unit delivers a broader frequency bandwidth (up to 18,000 Hz) as compared to existing devices for single-sided deafness. This broader bandwidth enhances spatial hearing ability, which is a key limitation for SSD patients. [11]

Treatment process

The patient is evaluated by an audiologist to determine degree of hearing loss to determine if the patient is a candidate for SoundBite. A dentist then performs a dental screening and takes a partial impression of the patient's teeth, which is used to create a customized SoundBite ITM device. The ITM and BTE are fitted and adjusted, and the system is programmed by a hearing professional. [10]

Candidates and indications

In the United States, SoundBite is appropriate for patients who are 18 years or older, with good oral health, with:

In Europe and Canada, SoundBite is appropriate for patients who are 18 years or older, with good oral health, with:

Manufacturer

The SoundBite Hearing System was manufactured by Sonitus Medical Inc., a privately held medical device company based in San Mateo, California founded in June 2006. In addition to receiving FDA clearance for SoundBite, Sonitus Medical has received CE Mark certification. The company filed for bankruptcy in January 2015 leaving users with no service and many who paid for these expensive devices never received them. Other companies have looked into buying them out but to date nobody has.

Related Research Articles

This is a glossary of medical terms related to communication disorders which are psychological or medical conditions that could have the potential to affect the ways in which individuals can hear, listen, understand, speak and respond to others.

<span class="mw-page-title-main">Anotia</span> Medical condition

Anotia describes a rare congenital deformity that involves the complete absence of the pinna, the outer projected portion of the ear, and narrowing or absence of the ear canal. This contrasts with microtia, in which a small part of the pinna is present. Anotia and microtia may occur unilaterally or bilaterally. This deformity results in conductive hearing loss, deafness.

<span class="mw-page-title-main">Vestibulocochlear nerve</span> Cranial nerve VIII, for hearing and balance

The vestibulocochlear nerve or auditory vestibular nerve, also known as the eighth cranial nerve, cranial nerve VIII, or simply CN VIII, is a cranial nerve that transmits sound and equilibrium (balance) information from the inner ear to the brain. Through olivocochlear fibers, it also transmits motor and modulatory information from the superior olivary complex in the brainstem to the cochlea.

<span class="mw-page-title-main">Otosclerosis</span> Condition characterized by an abnormal bone growth in the middle ear

Otosclerosis is a condition of the middle ear where portions of the dense enchondral layer of the bony labyrinth remodel into one or more lesions of irregularly-laid spongy bone. As the lesions reach the stapes the bone is resorbed, then hardened (sclerotized), which limits its movement and results in hearing loss, tinnitus, vertigo or a combination of symptoms. The term otosclerosis is something of a misnomer: much of the clinical course is characterized by lucent rather than sclerotic bony changes, so the disease is also known as otospongiosis.

<span class="mw-page-title-main">Hearing aid</span> Electroacoustic device

A hearing aid is a device designed to improve hearing by making sound audible to a person with hearing loss. Hearing aids are classified as medical devices in most countries, and regulated by the respective regulations. Small audio amplifiers such as personal sound amplification products (PSAPs) or other plain sound reinforcing systems cannot be sold as "hearing aids".

Bone conduction is the conduction of sound to the inner ear primarily through the bones of the skull, allowing the hearer to perceive audio content even if the ear canal is blocked. Bone conduction transmission occurs constantly as sound waves vibrate bone, specifically the bones in the skull, although it is hard for the average individual to distinguish sound being conveyed through the bone as opposed to the sound being conveyed through the air via the ear canal. Intentional transmission of sound through bone can be used with individuals with normal hearing — as with bone-conduction headphones — or as a treatment option for certain types of hearing impairment. Bones are generally more effective at transmitting lower-frequency sounds compared to higher-frequency sounds.

<span class="mw-page-title-main">Conductive hearing loss</span> Medical condition

Conductive hearing loss (CHL) occurs when there is a problem transferring sound waves anywhere along the pathway through the outer ear, tympanic membrane (eardrum), or middle ear (ossicles). If a conductive hearing loss occurs in conjunction with a sensorineural hearing loss, it is referred to as a mixed hearing loss. Depending upon the severity and nature of the conductive loss, this type of hearing impairment can often be treated with surgical intervention or pharmaceuticals to partially or, in some cases, fully restore hearing acuity to within normal range. However, cases of permanent or chronic conductive hearing loss may require other treatment modalities such as hearing aid devices to improve detection of sound and speech perception.

<span class="mw-page-title-main">Sensorineural hearing loss</span> Hearing loss caused by an inner ear or vestibulocochlear nerve defect

Sensorineural hearing loss (SNHL) is a type of hearing loss in which the root cause lies in the inner ear or sensory organ or the vestibulocochlear nerve. SNHL accounts for about 90% of reported hearing loss. SNHL is usually permanent and can be mild, moderate, severe, profound, or total. Various other descriptors can be used depending on the shape of the audiogram, such as high frequency, low frequency, U-shaped, notched, peaked, or flat.

<span class="mw-page-title-main">Weber test</span> Screening test for hearing

The Weber test is a screening test for hearing performed with a tuning fork. It can detect unilateral (one-sided) conductive hearing loss and unilateral sensorineural hearing loss. The test is named after Ernst Heinrich Weber (1795–1878). Conductive hearing ability is mediated by the middle ear composed of the ossicles: the malleus, the incus, and the stapes. Sensorineural hearing ability is mediated by the inner ear composed of the cochlea with its internal basilar membrane and attached cochlear nerve. The outer ear consisting of the pinna, ear canal, and ear drum or tympanic membrane transmits sounds to the middle ear but does not contribute to the conduction or sensorineural hearing ability save for hearing transmissions limited by cerumen impaction.

The Rinne test is used primarily to evaluate loss of hearing in one ear. It compares perception of sounds transmitted by air conduction to those transmitted by bone conduction through the mastoid. Thus, one can quickly screen for the presence of conductive hearing loss.

Unilateral hearing loss (UHL) is a type of hearing impairment where there is normal hearing in one ear and impaired hearing in the other ear.

<span class="mw-page-title-main">Microtia</span> Medical condition

Microtia is a congenital deformity where the auricle is underdeveloped. A completely undeveloped pinna is referred to as anotia. Because microtia and anotia have the same origin, it can be referred to as microtia-anotia. Microtia can be unilateral or bilateral. Microtia occurs in 1 out of about 8,000–10,000 births. In unilateral microtia, the right ear is most commonly affected. It may occur as a complication of taking Accutane (isotretinoin) during pregnancy.

<span class="mw-page-title-main">Bone-anchored hearing aid</span>

A bone-anchored hearing aid (BAHA) is a type of hearing aid based on bone conduction. It is primarily suited for people who have conductive hearing losses, unilateral hearing loss, single-sided deafness and people with mixed hearing losses who cannot otherwise wear 'in the ear' or 'behind the ear' hearing aids. They are more expensive than conventional hearing aids, and their placement involves invasive surgery which carries a risk of complications, although when complications do occur, they are usually minor.

A contralateral routing of signals (CROS) hearing aid is a type of hearing aid that is used to treat a condition in which the patient has no usable hearing in one ear and minimal hearing loss or normal hearing in the other ear. This is referred to as single sided deafness.

<span class="mw-page-title-main">Pure-tone audiometry</span>

Pure-tone audiometry is the main hearing test used to identify hearing threshold levels of an individual, enabling determination of the degree, type and configuration of a hearing loss and thus providing a basis for diagnosis and management. Pure-tone audiometry is a subjective, behavioural measurement of a hearing threshold, as it relies on patient responses to pure tone stimuli. Therefore, pure-tone audiometry is only used on adults and children old enough to cooperate with the test procedure. As with most clinical tests, standardized calibration of the test environment, the equipment and the stimuli is needed before testing proceeds. Pure-tone audiometry only measures audibility thresholds, rather than other aspects of hearing such as sound localization and speech recognition. However, there are benefits to using pure-tone audiometry over other forms of hearing test, such as click auditory brainstem response (ABR). Pure-tone audiometry provides ear specific thresholds, and uses frequency specific pure tones to give place specific responses, so that the configuration of a hearing loss can be identified. As pure-tone audiometry uses both air and bone conduction audiometry, the type of loss can also be identified via the air-bone gap. Although pure-tone audiometry has many clinical benefits, it is not perfect at identifying all losses, such as ‘dead regions’ of the cochlea and neuropathies such as auditory processing disorder (APD). This raises the question of whether or not audiograms accurately predict someone's perceived degree of disability.

A direct acoustic cochlear implant - also DACI - is an acoustic implant which converts sound in mechanical vibrations that stimulate directly the perilymph inside the cochlea. The hearing function of the external and middle ear is being taken over by a little motor of a cochlear implant, directly stimulating the cochlea. With a DACI, people with no or almost no residual hearing but with a still functioning inner ear, can again perceive speech, sounds and music. DACI is an official product category, as indicated by the nomenclature of GMDN.

<span class="mw-page-title-main">MED-EL</span> Multinational medical device company

MED-EL is a global medical technology company specializing in hearing implants and devices. They develop and manufacture products including cochlear implants, middle ear implants and bone conduction systems. 

Cartilage conduction is a pathway by which sound signals are transmitted to the inner ear. In 2004, Hiroshi Hosoi discovered this pathway and named “cartilage conduction”. Hearing by cartilage conduction is distinct from conventional sound-conduction pathways, such as air or bone, because it is realized by touching a transducer on the aural cartilage and does not involve the vibration of the skull bone. Therefore, cartilage conduction is referred to as the “third auditory pathway”.

<span class="mw-page-title-main">Diagnosis of hearing loss</span>

Identification of a hearing loss is usually conducted by a general practitioner medical doctor, otolaryngologist, certified and licensed audiologist, school or industrial audiometrist, or other audiometric technician. Diagnosis of the cause of a hearing loss is carried out by a specialist physician or otorhinolaryngologist.

A middle ear implant is a hearing device that is surgically implanted into the middle ear. They help people with conductive, sensorineural or mixed hearing loss to hear. 

References

  1. "Sonitus Medical to Hold Auction After Closing Its Doors". 2015-02-10.
  2. "CMS Killed My $80M Venture-Backed Startup | MDDI Medical Device and Diagnostic Industry News Products and Suppliers". mddionline. Archived from the original on 2015-04-07.
  3. "Who Has Hearing Loss". Hearing Loss Education Center. Retrieved 22 February 2012.
  4. Dimmelow, K.L. "Hear on the other side" (PDF). SingleSidedDeafness. Retrieved 22 February 2012.
  5. "Medicare Benefit Policy Manual" (PDF). United States Government. Retrieved 23 February 2012.
  6. George, A P; De, R (February 2010). "Review of temporal bone dissection teaching: how it was, is and will be". The Journal of Laryngology & Otology. 124 (2): 119–25. doi: 10.1017/S0022215109991617 . PMID   19954559.
  7. Ozer, Eyal; Adelman; Freeman; Sohmer (27 May 2002). "Bone conduction hearing on the teeth of the lower jaw". Journal of Basic and Clinical Physiology and Pharmacology. 13 (2): 89–96. doi:10.1515/JBCPP.2002.13.2.89. PMID   16411423. S2CID   30021076.
  8. Murray, Michael; Popelka, Miller (1 April 2011). "Efficacy and Safety of an In-the-Mouth Bone Conduction Device for Single-Sided Deafness". Otology & Neurotology. 32 (3): 437–443. doi:10.1097/MAO.0b013e3182096b1d. PMID   21221045. S2CID   5286526.
  9. Gurgel, Richard K.; Shelton, Clough (2013). "The SoundBite Hearing System: Patient-Assessed Safety and Benefit Study". The Laryngoscope. 123 (11): 2807–2812. doi:10.1002/lary.24091. PMID   23856912. S2CID   5331746.
  10. 1 2 3 Miller, Ross (5 November 2010). "It's time we listened to our teeth:The SoundBite hearing system". American Journal of Orthodontics and Dentofacial Orthopedics. 138 (5): 666–669. doi: 10.1016/j.ajodo.2010.03.027 . PMID   21055609 . Retrieved 22 February 2012.
  11. Popelka, Gerald; Derebery J.; Blevins N.; Murray M.; Moore B.; Sweetow R.; Wu B.; Katsis M. (2 April 2010). "Preliminary Evaluation of a Novel Bone-Conduction Device for Single-Sided Deafness". Otology & Neurotology. 31 (3): 492–497. doi:10.1097/MAO.0b013e3181be6741. PMID   19816229. S2CID   36906407.