“…Second, as nearly all implanted patients wear glasses—at least sunglasses—patients reported pain and pressure marks when the temples were near or in contact with the transducer. This complication was also reported by Lau et al [ 3 ] Fig. 2 Patients with retroauricular bump of the Osia® implant …”
Section: Introductionsupporting
confidence: 76%
“…Second, as nearly all implanted patients wear glasses-at least sunglassespatients reported pain and pressure marks when the temples were near or in contact with the transducer. This complication was also reported by Lau et al [3] To reduce these complaints, we needed a surgical method to implant the OSI that led to a smaller or absent bump behind the patient's ear.…”
Background
The Cochlear™ Osia® System leaves a retroauricular bump that can cause discomfort and poor aesthetic outcome.
Method
To reduce the retroauricular bump, we introduced an implant well in the bone behind the ear for the transducer. We used cutting and diamond drills to create the implant well with an average depth of 4–5 mm. The surgical time including the implant well (40 min) was within the range of reported average surgical time (52 min).
Conclusion
Introduction of an implant well resulted in a better aesthetic outcome and improved patients’ comfort. The reduced distance between BI300 and ear canal might improve audiological outcome.
“…Second, as nearly all implanted patients wear glasses—at least sunglasses—patients reported pain and pressure marks when the temples were near or in contact with the transducer. This complication was also reported by Lau et al [ 3 ] Fig. 2 Patients with retroauricular bump of the Osia® implant …”
Section: Introductionsupporting
confidence: 76%
“…Second, as nearly all implanted patients wear glasses-at least sunglassespatients reported pain and pressure marks when the temples were near or in contact with the transducer. This complication was also reported by Lau et al [3] To reduce these complaints, we needed a surgical method to implant the OSI that led to a smaller or absent bump behind the patient's ear.…”
Background
The Cochlear™ Osia® System leaves a retroauricular bump that can cause discomfort and poor aesthetic outcome.
Method
To reduce the retroauricular bump, we introduced an implant well in the bone behind the ear for the transducer. We used cutting and diamond drills to create the implant well with an average depth of 4–5 mm. The surgical time including the implant well (40 min) was within the range of reported average surgical time (52 min).
Conclusion
Introduction of an implant well resulted in a better aesthetic outcome and improved patients’ comfort. The reduced distance between BI300 and ear canal might improve audiological outcome.
“…Safety and effectiveness of the Osia system have been proved, e.g., by Lau et al [ 7 ], and results from 12-month follow-up of a large cohort were published by Mylanus et al [ 8 ]. However, long-term data above 12 months’ time have not been published to date, and we want to close this gap with our study assessing both objective and subjective outcomes of Osia implantation.…”
Purpose
The new active transcutaneous partially implantable osseointegrated system Cochlear™ Osia® System is indicated in case of conductive or mixed hearing loss (CHL/MHL) with a maximum average bone conduction hearing loss of 55 dB, or in single-sided deafness (SSD). The implant directly stimulates the bone via a piezoelectric transducer and is directed by an external sound processor. We conducted a monocentric retrospective longitudinal within-subject clinical study at our tertiary academic referral center. The aim was to investigate long-term data (2017–2021) on audiological outcomes and hearing-related quality of life for the Osia system.
Methods
Between 2017 and 2020, 22 adults (18: CHL/MHL; 3: SSD) were implanted with the Osia100 implant; seven received bilateral implants. As of 10/2020, the sound processor was upgraded to Osia 2.
Results
Mean Osia system use by 04/2021 was 30.9 ± 8.6 months (range 17–40 months). Unaided bone conduction thresholds were unchanged postoperatively. One patient had to be explanted because of prolonged wound infection. Aided hearing thresholds were significantly lower compared to the unaided thresholds preoperatively, along with a marked increase in speech recognition in quiet. Speech processor upgrade resulted in a stable benefit. Patients with CHL/MHL and SSD showed a similar improvement in self-rated hearing performance revealed by SSQ, APHAB, and HUI questionnaires.
Conclusion
The Osia system is a safe, effective and sustainable option for treatment of conductive and mixed hearing loss or single-sided deafness.
“…The low profile of the implant, made possible by the slim design of the piezoelectric actuator, allows for minimal bone removal compared with other active transcutaneous systems, which require the electromagnetic actuator to be recessed. This ability to place the actuator on the bone surface negates the requirement for it to be recessed, making the surgery more straightforward ( 21 ). The single-component design of the implant also permits for some surgical versatility, and it was possible to successfully position the coil above the muscle in some patients, further simplifying the surgery and reducing operating time.…”
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.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
