Clinical Performance, Safety, and Patient-Reported Outcomes of an Active Osseointegrated Steady-State Implant System.
Otol Neurotol
; 43(7): 827-834, 2022 08 01.
Article
in En
| MEDLINE
| ID: mdl-35878640
ABSTRACT
OBJECTIVE:
To investigate the clinical performance, safety, and patient-reported outcomes of an active osseointegrated steady-state implant system that uses piezoelectric technology. STUDYDESIGN:
A prospective, multicenter, open-label, single-arm, within-subject clinical investigation.SETTING:
Three tertiary referral clinical centers located in Melbourne, Sydney, and Hong Kong. PATIENTS Twenty-nine adult subjects, 24 with mixed hearing loss or conductive hearing loss and 5 with single-sided sensorineural deafness. INTERVENTION Implantation with the Cochlear Osia 2 System. MAIN OUTCOMEMEASURES:
Audiological threshold evaluation and speech recognition in quiet and in noise. Patient satisfaction and safety.RESULTS:
At 6-month follow-up after surgery, a mean improvement in pure-tone average of 26.0 dB hearing level and a mean improvement of 8.8 dB signal-to-noise ratio in speech reception threshold in noise was achieved with the investigational device as compared with the unaided situation. Usability of the investigational device was rated 71.4/100 mm for sound processor retention and 81.4/100 mm for overall comfort using a visual analog scale.CONCLUSION:
These outcomes confirm the clinical safety, performance, and benefit of an innovative active transcutaneous bone conduction implant using a piezoelectric transducer design in subjects with conductive hearing loss, mixed hearing loss, or single-sided sensorineural deafness.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Speech Perception
/
Deafness
/
Hearing Loss, Mixed Conductive-Sensorineural
/
Hearing Aids
/
Hearing Loss
/
Hearing Loss, Sensorineural
Type of study:
Clinical_trials
/
Observational_studies
Aspects:
Patient_preference
Limits:
Adult
/
Humans
Language:
En
Journal:
Otol Neurotol
Journal subject:
NEUROLOGIA
/
OTORRINOLARINGOLOGIA
Year:
2022
Document type:
Article