Middle Ear Implants
|Middle ear implants are available to hearing-impaired patients who are dissatisfied with conventional hearing aids. The Vibrant Soundbridge provides wonderful acoustic results in selected patients. It is currently the only middle ear implant approved by the FDA for the treatment of hearing loss. It is manufactured by the Med El Corporation and over 2300 patients have been implanted internationally. It is a good alternative for an acoustic hearing aid. This device is an excellent choice for patients experiencing difficulty with their own voice quality due to occlusion, feedback or reverberation issues with conventional hearing aids. It is also beneficial for patients who are experiencing multiple hearing aid repairs due to debris or cerumen or someone interested in a more comfortable hearing solution. With the Soundbridge device the ear canal remains unoccluded.
The Vibrant Soundbridge is a semi-implantable device that has been FDA approved for the treatment of sensorineural hearing loss. The Vibrant Soundbridge has been shown to be a safe alternative to hearing aids in people with sensorineural, or nerve hearing loss who cannot or do not wish to wear a hearing aid. Dr. Maw was an investigating surgeon of the FDA trail for sensorineural hearing loss, and implanted 14 patients with the device during the clinical trial. Patients experienced many benefits from the device, including a significant improvement in clarity and overall sound quality compared to their hearing aids. The device also eliminated the problems that hearing aids can cause, such as ear canal problems, amplification of background noise and distortion of sounds. They also perceived a major benefit of the Soundbridge in many listening situations compared to their hearing aids including entertainment settings such as television movies, radio and theater. Most patients experienced no change in their unaided hearing after surgery.
What is the Soundbridge®?
The Vibrant Soundbridge is a new category of implantable middle ear hearing device. The implant directly vibrates the small bones in the middle ear. The Soundbridge is indicated for use in adults, 18 years or older, with a moderate to severe sensorineural hearing loss and no interest in conventional hearing aids. The Soundbridge is the first FDA approved implantable middle ear hearing device to treat sensorineural hearing loss.. A proven, safe and effective treatment that leaves the ear canal completely open, the Soundbridge features a 94 percent improvement in patient satisfaction, with thousands of patients worldwide. The Soundbridge is intended for use in adults (18 years or older) who have moderate-to-severe sensorineural hearing loss and desire an alternative to an acoustic hearing aid.
How does the Soundbridge work?
The Vibrant Soundbridge utilizes a hearing technology that directly drives the ossicular chain (middle ear bones), bypassing the ear canal and tympanic membrane. It consists of two major components:
|Internal receiver and the tiny floating mass transducer
- The implant, called the Vibrating Ossicular Prosthesis™ (VORPTM), and,
- The externally-worn receiver, called the Audio Processor™ (approximately the size of a quarter).
The Soundbridge is a direct drive device which mechanically vibrates the bones in the middle ear without surgically altering the structures of the middle ear.
The tiny Floating Mass Transducer™, attached to the incus bone in the middle ear, is approximately the size of a grain of rice. It is 100 percent digital and is programmed by an Audiologist eight weeks after the implant procedure to fit the user's specific hearing loss. The Soundbridge converts sound into mechanical energy which is directly transmitted to the auditory ossicles.
The external audio processor picks up the sound from the environment and transmits it across the skin to the receiver of the VORP. The signal is then transmitted to the Floating Mass Transducer (FMT) causing it to vibrate. The FMT mechanically stimulates the ossicles, mimicking the natural process of hearing. The VORP is surgically implanted under the skin behind the ear. The FMT is attached to the long process of the “incus” bone during the surgical process. The ossicular motion creates a movement in the cochlea, stimulating the hair cells. The hair cells provide stimuli to the auditory nerve, which is interpreted as sound by the brain.
The Floating Mass Transducer
The selection colors available for the audio processor.
Is the Soundbridge effective?
Yes. The efficacy of implantation of the Soundbridge on residual hearing was evaluated by several different clinical measures. A shift in pure-tone averages (PTAs) of less than 10 dB at three months after activation was seen in 96 percent of study participants. The mean shift in PTA was 2.7 dB for all of the subjects. The Soundbridge yielded a mean improvement in functional gain at all frequencies and greater than 10 dB at 2000, 4000 and 6000 Hz. Additionally, the number of subjects who reported improvement was significant across all seven subscales compared with the presurgery aided condition (familiar talkers, ease of communication, reverberation, reduced cues, background noise, aversiveness of sounds, and distortion of sounds).
What makes the Soundbridge different from cochlear implants or hearing aids?
The Soundbridge is not a cochlear implant and it is not currently approved for conductive hearing loss. Cochlear implants are for the estimated 10 percent of the hearing-impaired population who suffer from severe to profound hearing loss. They are implanted directly in the inner ear, or cochlea, where they electronically stimulate the nerves through a series of electrodes. In contrast, the Soundbridge is implanted in the middle ear and is for the 60 percent of hearing-impaired people with moderate-to-severe sensorineural hearing loss.
Hearing aids, which are worn in the ear canal, amplify sound acoustically in order to increase the movement of the eardrum and indirectly vibrate the middle ear bones. In contrast, the Soundbridge provides an enhanced signal to the inner ear by directly vibrating the middle ear bones while leaving the ear canal open and the eardrum undisturbed.
Patients generally wear the device all day (as long as sixteen hours) and generally report a “more natural sound,” better speech understanding and like the device much better than hearing aids . For many patients who cannot wear hearing aids due to medical necessity, a middle ear implant like the Soundbridge is the only available alternative.
Who is a good candidate for the Soundbridge?
With nothing in the ear canal, the Soundbridge is a particularly good treatment option for current hearing aid wearers who suffer from occlusion or feedback, and those who are looking for better sound quality or improved cosmetics. Occlusion is the sensation of hearing distorted, muffled sounds experienced when an object blocks the ear canal. It is a common complaint among hearing aid users, who often find that the presence of the hearing aid, or hearing aid ear mold, in their ear canal distorts not only outside sounds but also the sound of their own voice. People who experience a hearing loss due to disease or trauma to the middle ear are not candidates for the device. To be a candidate for this procedure, patients should meet the following criteria:
- Moderate to severe sensorineural hearing loss.
- Normal middle ear function.
- 50 % minimum speech recognition score at the implant ear under headphones.
- Realistic expectations and highly motivated.
- Stable hearing loss.
What is the surgery like?
The procedure to implant the Soundbridge is done on an outpatient basis and it takes approximately one and a half to two hours. Implant patients are exposed to the normal risks of middle ear surgery and general anesthesia. The surgery is performed under general anesthesia. There is minimal post-opertive pain. An incision is made being the ear and a bed is made for the internal receiver. The mastoid bone is opened and the middle ear is then entered through the mastoid and the floating mass transducer is placed on the incus. The internal receiver is sutured to the skull and the skin is closed. A dressing is worn for one day. Sutures are self-dissolving and the patient can resume most activities the next day. The external processor is fitted 3 weeks after surgery. At activation, the device is connected to the Siemens programming software and programmed for the individual’s hearing loss.
How much does the Soundbridge cost? Is it covered by insurance?
Many private insurance companies-- HMO, PPO, or fee for service -- cover the Soundbridge implant procedure. Clinics have been provided with a manual to assist with the reimbursement process. Currently, Medicare and Medicaid coverage is not available.
THE SOUNDBRIDGE FOR CONDUCTIVE AND MIXED HEARING LOSS
The Soundbridge is now being investigated by Dr. Maw for the treatment of conductive and mixed hearing losses, which can occur in patients with chronic disease of the middle ear. It can be placed at the opening to the inner ear, the round window, bypassing the middle ear bones which may be absent or diseased, and therefore eliminates the conductive, or mechanical hearing loss of the ear. It can also amplify sound to overcome a sensorineural, or nerve hearing loss, if also present. After surgery, the device is programmed to compensate for the loss of sensitivity of the inner ear. In the current study, the Vibrant Soundbridge is being evaluated for patients who have middle ear problems that cannot be resolved with other surgical procedures, or in patients who have persisting mechanical middle ear problems after previous ear surgery. This is a clinical scenario that is frequently encountered by ear surgeons, and is often caused by poor function of the Eustachian tube, the tube which connects the middle ear to the back of the nose.
“I am extremely enthusiastic about this new study” reports Dr. Maw. “This procedure has the potential to revolutionize how ear surgeons treat chronic ear disease and hearing loss. Eustachian tube dysfunction limits the hearing results that patients can achieve with reconstructive ear surgery, and there are no well-established treatments for this problem. As this device can mimic the function of the middle ear, we can potentially help a large category of patients who could not be previously considered as suitable surgical candidates”.
Soundbridge placement in the round window in an ear without ossicles.
Related Link: www.MedEL.com