SAN MATEO, Calif., Aug. 12, 2014 /PRNewswire/ -- Two recently published peer-reviewed studies suggest that the non-surgical SoundBite™ Hearing System can offer benefits over surgical, osseointegrated Bone-Anchored Hearing Implants (BAHI) for single-sided deafness patients.
Published in the International Journal of Audiology, the first study by Moore et al., "Preliminary Comparison of Bone-Anchored Hearing Instruments and a Dental Device as Treatments for Unilateral Hearing Loss" reports on 9 single-sided deaf patients. Each study participant wore SoundBite and BAHI for 30 days in randomized order and their experience was compared via the clinically validated APHAB questionnaire and sound field testing.
The study concludes that SoundBite delivered "consistently greater benefit" for patients compared to BAHI, as assessed by APHAB scores. Sound field scores aided by each device also were on average 10 decibels better for SoundBite. After the study, 44% of subjects elected to take an additional step to undergo a procedure to remove their BAHI abutment.
A second recently published study that compared device capabilities may shed light on the reasons for these clinical results. This study by Syms et al.—entitled "Bone Conduction Hearing: Device Auditory Capability to Aid in Device Selection", published in Otolaryngology – Head & Neck Surgery—evaluated the output of 8 BAHI devices and SoundBite across a full range of audible frequencies.
The study established that all devices had adequate output across most frequencies, but that SoundBite has advantages in output and gain at high frequencies. High-frequency device performance is particularly important for hearing in noisy environments and understanding speech.
"The differences in device performance reported in this study help physicians select the right device for each patient. We know that high frequency performance is critical to speech understanding and hearing in noise. SoundBite is a better solution in this range, precisely where single-sided deaf patients need support the most," said Mark J. Syms, M.D. of The Arizona Ear Center, and lead author of the study.
About the patients affected: Single-sided deafness is caused by tumors, trauma, infections, or other illnesses, and is characterized by a significant or permanent hearing loss in one ear and relatively normal hearing in the other ear. Patients suffer from reduced quality of life among other consequences.
About SoundBite: An innovation in hearing-prosthetic technology, SoundBite transmits sound using the well-established principle of bone conduction to restore the perception of hearing in both ears. Unlike other devices that route sound through skull bones, SoundBite uses the patient's teeth to transfer sound from the impaired ear to the working ear. This system removes the need for a surgical implant in the skull which eliminates the costs and complications of surgery. SoundBite is FDA cleared for Single-Sided Deafness and Conductive Hearing Loss in patients age 18 and older.
Syms MJ, Hernandez KE, "Bone conduction hearing: device auditory capability to aid in device selection," Otolaryngology-Head & Neck Surgery." 2014, 150: 866-871.
Moore B, Popelka, GR, "Preliminary comparison of bone-anchored hearing instruments and a dental device as treatments for unilateral hearing loss," International Journal of Audiology. 2013, 10: 678-86.
SOURCE Sonitus Medical, Inc.