Digital Hearing Device – Surgical Implants In The Middle Ear

Sensorineural hearing loss (nerve deafness) is the most common type of hearing loss in the United States, affecting more than twenty-three percent of Americans older than 65. Until recently, these individuals had one option – a traditional acoustic hearing aid.

The hard of hearing community was recently introduced to the Vibrant Soundbridge, a surgically implantable middle ear device that directly vibrates the bones of the middle ear. Its manufacturers stated that the device represented an entirely new approach to the treatment of sensorineural hearing loss. Since its FDA clearance in August 2000, patients in the United States and Europe have had this device implanted for hearing assistance.

A short-term study has been conducted to assess patient satisfaction and the product's safety and efficacy. The authors of the “Long-Term Results with the Vibrant Soundbridge: First 100 US Patients" are Thomas J. Balkany, MD, from the University of Miami Ear Institute in Miami, FL, and Charles M. Luetje MD, of the Otologic Group, Kansas City, MO, on May 10, 2002, at the Annual Meeting of the American Neurotology Society, being held at Boca Raton Resort & Club, Boca Raton, FL. Both are members of the Vibrant Soundbridge Study Group.

Methodology: One hundred adults with mild-to-severe sensorineural hearing loss meeting the following criteria were chosen to participate in the study at 15 tertiary care hospital and outpatient facilities: SRT (speech recognition threshold) of 30 dB or greater, hearing aid user for a minimum of three months prior to implantation, absence of conductive, retrocochlear or central involvement, symmetrical hearing loss, word recognition greater than 50 percent under earphones, normal middle ear anatomy and function.

Each patient underwent otologic examination, audiometric testing, and self-assessment prior to implantation and at post-operative intervals of two months, three months, five months (study endpoint), and subsequently at 12-month intervals. The Vibrant Soundbridge was implanted surgically under an FDA-approved protocol.

Results: Outcomes of the study were measured by residual hearing, functional gain, speech recognition, satisfaction and adverse events.

Residual hearing, tested as an indicator of safety, remained at 96 percent. Functional gain, defined as improvement in the level of hearing over previous hearing aid use, was increased by a minimum of 10dB in all patients. No improvement was seen in speech recognition scores. Patient satisfaction with the performance of the Vibrant Soundbridge was significant; eighty-one percent reported improvement in quality of life. Adverse events were reported as a further measurement of safety; problems reported include: device failure, transient facial paresis, infection, episodic dizziness, change in residual hearing, perforated tympanic membrane, altered taste sensation, skin irritation, transient pain, and device malfunction.

Conclusion: The researchers found that the Vibrant Soundbridge is a safe and effective long-term alternative to traditional acoustic hearing aids for adults with mild to severe sensorineural hearing loss who meet specific criteria. Patients exceeding the selection criteria should not be implanted. Those younger than 18 should be advised that additional hearing loss might occur over time, rendering the device less effective.

About The Author:

Jen Bead is a successful author and regular contributor to http://www.digital-hearing-aids-n-protection.com. Finding out more about hearing loss, so you can choose the digital hearing aids or therapy that is necessary.