Early clinical results: SOUNDTEC implantable hearing device phase II study.
Laryngoscope
; 111(1): 1-8, 2001 Jan.
Article
en En
| MEDLINE
| ID: mdl-11192875
ABSTRACT
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. STUDYDESIGN:
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.CONCLUSION:
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.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Prótesis e Implantes
/
Fenómenos Electromagnéticos
/
Audífonos
Tipo de estudio:
Clinical_trials
/
Guideline
/
Observational_studies
/
Prognostic_studies
Aspecto:
Patient_preference
Límite:
Aged
/
Female
/
Humans
/
Male
Idioma:
En
Revista:
Laryngoscope
Asunto de la revista:
OTORRINOLARINGOLOGIA
Año:
2001
Tipo del documento:
Article
País de afiliación:
Estados Unidos