Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
A/Prof Jean-Marc Gerard, Royal Victorian Eye and Ear Hospital, Melbourne, Australia
Authors List
Introduction
Bone conduction hearing implants (BCHI) are an established means of aural habilitation/rehabilitation for individuals with conductive hearing loss (CHL), mixed hearing loss (MHL) or single-sided deafness (SSD). Recently, active transcutaneous BCHI’s have been introduced and designed to combine the benefits of transcutaneous solutions with the more efficient transfer capabilities of percutaneous systems.
Aims
To investigate the clinical performance, safety, and patient-reported outcomes of an active osseointegrated steady-state implant system that uses piezoelectric technology (Cochlear Osia 2 System).
Methods
A prospective, multicentre, open-label, single-arm, within subject clinical investigation with main outcome measures as audiological threshold evaluation, speech recognition in quiet and in noise, and patient satisfaction and safety.
Results
Twenty-nine adult subjects, 24 with mixed hearing loss (MHL) or conductive hearing loss (CHL) and 5 with single-sided sensorineural deafness (SSD). At six-month follow-up post-surgery, a mean improvement, compared to the unaided situation, in pure tone average of 26.0 dB HL and a mean improvement of 8.8 dB SNR in speech reception threshold in noise was achieved with the investigational device. 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 analogue scale.
Conclusions
These outcomes confirm the clinical safety, performance, and benefit of an innovative active transcutaneous bone conduction implant employing a piezoelectric transducer design in subjects with CHL, MHL, or SSD.
- Jean-Marc Gerard, The Royal Victorian Eye and Ear Hospital, Melbourne, Australia
- Robert Briggs, The Royal Victorian Eye and Ear Hospital, Melbourne, Australia
- Catherine Birman, Next Sense, NSW, Australia
- Michael Tong, Institute of Human Communicative Research and Department of Otorhinolaryngology, Head and Neck Surgery, the Chinese University of Hong Kong, Hong Kong SAR, PRC
- Robert Cowan, The Royal Victorian Eye and Ear Hospital, Melbourne, Australia
Introduction
Bone conduction hearing implants (BCHI) are an established means of aural habilitation/rehabilitation for individuals with conductive hearing loss (CHL), mixed hearing loss (MHL) or single-sided deafness (SSD). Recently, active transcutaneous BCHI’s have been introduced and designed to combine the benefits of transcutaneous solutions with the more efficient transfer capabilities of percutaneous systems.
Aims
To investigate the clinical performance, safety, and patient-reported outcomes of an active osseointegrated steady-state implant system that uses piezoelectric technology (Cochlear Osia 2 System).
Methods
A prospective, multicentre, open-label, single-arm, within subject clinical investigation with main outcome measures as audiological threshold evaluation, speech recognition in quiet and in noise, and patient satisfaction and safety.
Results
Twenty-nine adult subjects, 24 with mixed hearing loss (MHL) or conductive hearing loss (CHL) and 5 with single-sided sensorineural deafness (SSD). At six-month follow-up post-surgery, a mean improvement, compared to the unaided situation, in pure tone average of 26.0 dB HL and a mean improvement of 8.8 dB SNR in speech reception threshold in noise was achieved with the investigational device. 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 analogue scale.
Conclusions
These outcomes confirm the clinical safety, performance, and benefit of an innovative active transcutaneous bone conduction implant employing a piezoelectric transducer design in subjects with CHL, MHL, or SSD.
