Early clinical results: SOUNDTEC implantable hearing device phase II study.
OBJECTIVE
To assess the safety and efficacy of a new semi-implantable electromagnetic hearing device, the SOUNDTEC Direct Drive Hearing System (DDHS), and to compare its performance with that of subjects' previously worn, optimally fit hearing aids. Preliminary results for the first 10 subjects are presented.


METHODS
The protocol specified in the Investigational Device Exemption is used in this ongoing FDA phase II 100-subject multicenter clinical trial.


METHODS
For baseline, each subject is tested wearing his or her own optimally fit hearing aid in the ear to be implanted. Six-month postoperative outcome measures using the SOUNDTEC DDHS are compared with the baseline. Multiple objective and subjective outcomes (as listed under Results) were measured.


RESULTS
When compared with the subjects' optimally fit hearing aids, the SOUNDTEC DDHS provided an average improvement of 52% in functional gain (250-6000 Hz), 22% in aided thresholds, 3.8% for speech discrimination in quiet, 17% for speech in noise, 13.1% in articulation index scores, 28% in aided benefit, 27.3% in sound quality of speech, and a 16.7% increase in overall subject satisfaction. In addition, with the SOUNDTEC DDHS, subjects reported absence of acoustic feedback, little or no occlusive effects, and more natural sound perception.


CONCLUSIONS
Analysis of data on the first 10 subjects using the SOUNDTEC DDHS indicates positive outcomes regarding safety and efficacy, although the small sample size is not sufficient to permit valid statistical inferences to be drawn from our preliminary data. Results also demonstrate improvement in performance compared with the subjects' optimally fit hearing aids and an improvement in quality of life as demonstrated by objective and subjective tests and measures.
Hough
J V
JV
Hough Ear Institute and the Department Otorhinolaryngology-Head and Neck Surgery, University of Oklahoma Health Sciences Center, Oklahoma City 73112, USA. houghear@earthlink.net
Dyer
R K
RK
Matthews
P
P
Wood
M W
MW
D000368:Aged; D001307:Auditory Perception / Q000502:physiology; D001309:Auditory Threshold / Q000502:physiology; D055590:Electromagnetic Phenomena / Q000295:instrumentation*; D005246:Feedback; D005260:Female; D005500:Follow-Up Studies; D006309:Hearing / Q000502:physiology; D006310:Hearing Aids; D006801:Humans; D008297:Male; D009622:Noise; D017060:Patient Satisfaction; D019736:Prostheses and Implants; D011474:Prosthesis Design; D011788:Quality of Life; D012449:Safety; D013060:Speech / Q000502:physiology; D013067:Speech Perception / Q000502:physiology; D013201:Stapes Surgery / Q000295:instrumentation / Q000379:methods; D016896:Treatment Outcome