Dataset Information

Clinical Performance, Safety, and Patient-Reported Outcomes of an Active Osseointegrated Steady-State Implant System.

ABSTRACT:

Objective

To investigate the clinical performance, safety, and patient-reported outcomes of an active osseointegrated steady-state implant system that uses piezoelectric technology.

Study design

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 outcome measures

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.

SUBMITTER: Briggs R

PROVIDER: S-EPMC9348816 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Clinical Performance, Safety, and Patient-Reported Outcomes of an Active Osseointegrated Steady-State Implant System.

Briggs Robert R Birman Catherine S CS Baulderstone Nicholas N Lewis Aaran T AT Ng Iris H Y IHY Östblom Anna A Rousset Alex A Tari Sylvia S Tong Michael C F MCF Cowan Robert R

Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology 20220801 7

<h4>Objective</h4>To investigate the clinical performance, safety, and patient-reported outcomes of an active osseointegrated steady-state implant system that uses piezoelectric technology.<h4>Study design</h4>A prospective, multicenter, open-label, single-arm, within-subject clinical investigation.<h4>Setting</h4>Three tertiary referral clinical centers located in Melbourne, Sydney, and Hong Kong.<h4>Patients</h4>Twenty-nine adult subjects, 24 with mixed hearing loss or conductive hearing loss ...[more]

PMID: 35878640

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Dataset Information

Clinical Performance, Safety, and Patient-Reported Outcomes of an Active Osseointegrated Steady-State Implant System.

Objective

Study design

Setting

Patients

Intervention

Main outcome measures

Results

Conclusion

Publications

Clinical Performance, Safety, and Patient-Reported Outcomes of an Active Osseointegrated Steady-State Implant System.

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