U.S. Phase I preliminary results of use of the Otologics MET Fully-Implantable Ossicular Stimulator.
OBJECTIVE
The safety of the Otologics Fully-Implantable MET Ossicular Stimulator was assessed in adult patients with bilateral moderate to severe sensorineural hearing loss.


METHODS
Surgical implantation of the ossicular stimulator was performed. A repeated-measure, within-subjects design assessed safety and aided sound field thresholds and speech performances with the subject's own, appropriately fitted, walk-in hearing aid(s) and the Otologics Fully-Implantable MET Ossicular Stimulator.


RESULTS
Twenty patients were implanted and activated as part of the Phase I clinical trial. Results demonstrated 10-20 dB of functional gain across audiometric frequencies. Pure tone averages and monaural word recognition scores were slightly better for the walk-in-aided condition, while patient benefit scales favored the postoperative implant-aided conditions.


CONCLUSIONS
Although monaural word scores and aided thresholds favored the walk-in-aided condition, preliminary results indicate that the Otologics MET Fully-Implantable Ossicular Stimulator is an alternative to currently available hearing aids in patients with sensorineural hearing loss.
Jenkins
Herman A
HA
University of Colorado Health Sciences Center, Denver, CO 80262, USA. herman.jenkins@uchsc.edu
Atkins
James S
JS
Horlbeck
Drew
D
Hoffer
Michael E
ME
Balough
Ben
B
Arigo
Joseph V
JV
Alexiades
George
G
Garvis
William
W
D000328:Adult; D000368:Aged; D001301:Audiometry, Pure-Tone; D001309:Auditory Threshold; D001844:Bone Conduction; D004429:Ear Ossicles; D004432:Ear, Middle / Q000601:surgery*; D004558:Electric Stimulation; D005260:Female; D006310:Hearing Aids / Q000009:adverse effects; D006319:Hearing Loss, Sensorineural / Q000503:physiopathology / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D019736:Prostheses and Implants / Q000009:adverse effects; D013067:Speech Perception; D016896:Treatment Outcome; D014481:United States