Clinical Trial of the Vibrant Soundbridge as a Treatment for Conductive and Mixed Hearing Losses, Using Direct Round Window Cochlear Stimulation.
There will be 3 additional subjects (6 total) enrolled in this study at this site. The eligibility requirements are stringent therefore, not all subjects that consent will meet all criteria. Patients will be seen in the Otolaryngology clinic at Aston and surgery will be performed at the St. Paul Outpatient Surgery Center.
General: Adults, 18 years of age or older at time of implantation; English as the primary language; Appropriate motivation and expectation levels; Geographically and physically able to return to the investigational center for scheduled evaluations and follow-up appointments; At least a 28-day unsuccessful hearing aid trial (within the past 24 months prior to enrollment) with a hearing aid dispensed by a licensed audiologist or hearing aid acoustician. An unsuccessful hearing aid trial is characterized by one or more of the following: 1) Inability to use traditional amplification for more than two (2) hours per day; 2) Inability to be appropriately fit with traditional amplification, as judged by a licensed audiologist or hearing aid acoustician; 3) Unresolved acoustic feedback; 4) Inability to tolerate traditional amplification worn in the ear canal and/or behind the ear; 5) Medical condition that prevents daily use of traditional amplification. Persons who after being informed that a different hearing aid than the one they currently have may provide improved hearing, still request an implant; Ability to undergo general anesthesia.
Audiological: Audiological tests suggest either a conductive or mixed hearing loss. The non-implanted ear may fall outside these criteria; however, threshold levels may not be worse than severe sloping to profound.
* Conductive Hearing Loss: Pure-tone bone-conduction threshold levels in the ear to be implanted shall fall at or within the levels stated in Table 2 below. There should be an air-bone gap of 15 dB HL or more at three or more of the frequencies 500, 1000, 1500, 2000, 3000, and 4000 Hz. Pure-tone air-conduction levels should indicate the presence of at least a moderate hearing loss, i.e., pure-tone average (PTA4 of 0.5, 1.0, 2.0, and 4.0 kHz) of at least 41 dB HL. Air conduction levels are not limited on the upper end.
* Mixed Hearing Loss: Pure-tone bone conduction threshold levels in the ear to be implanted shall fall at or within the levels stated in Table 3 below. There should be an air-bone gap of 15 dB HL or more at three or more of the frequencies 500, 1000, 1500, 2000, 3000, and 4000 Hz. Bone conduction thresholds at least three of the frequencies should be 26 dB or greater. Pure-tone air-conduction thresholds should be, on average, at least moderately impaired, that is a PTA4 (5, 1.0, 2.0, and 4.0 kHz) of 41 dB or greater. Airconduction levels are not limited on the upper end.
Good potential for aided speech recognition as indicated by a pre-operative monosyllabic word score of > 30% in the ear to be implanted as measured under headphones at 40 dB SL or at MCL
Hearing aid trial with appropriately fitted hearing aids of at least 28 days duration within the past 24 months, unless the subject is unable to wear hearing aids for medical reasons
Most recent audiometric data, if available, judged to be of good test-retest reliability.