Multicenter Clinical Investigation of a New Active Osseointegrated Steady-State Implant System

Mylanus, Emmanuel A. M.; Hua, Håkan; Wigren, Stina; Arndt, Susan; Skarżyński, Henryk; Telian, Steven A.; Briggs, Robert

doi:10.1097/mao.0000000000002794

Cited by 32 publications

(93 citation statements)

References 31 publications

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“…Recently, the first clinical studies have been published using this new system. In a recent study from Mylanus et al, a comparison between preoperative performance using a passive transcutaneous system (Baha BP110 on Softband) and postoperative outcomes with Osia showed significant improvement in speech perception and a reduction in aided hearing thresholds [ 38 ]. Similarly, Goycoolea et al compared preoperative functional outcomes with a different passive transcutaneous device (Baha 5 Power on Softband) with postoperative results obtained with Osia.…”

Section: Discussionmentioning

confidence: 99%

The Impact of Location and Device Coupling on the Performance of the Osia System Actuator

Fierens

Borgers

Putzeys

et al. 2022

BioMed Research International

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Active transcutaneous bone conduction (BC) devices offer the benefit of improved power output compared to passive transcutaneous devices and remove the risk of skin infections that are more common in traditional percutaneous BC devices. Despite these advantages, more research is needed on implant location, device coupling, and their influence on device performance. This study is aimed at quantifying the extent to which certain parameters affect device output when using the Osia® system actuator. Parameters under study are (1) implant location, (2) comparison with the actuator of a state-of-the-art BC device, (3) bone undergrowth simulation, and (4) skull fixation. Five human cadaveric heads were implanted with the actuator at three different implant locations: (1) recommended, (2) posterior Osia® positions, and (3) standard Baha® position. At each location, the cochlear promontory velocity and the intracochlear pressure difference were measured. A percutaneous bone conduction actuator was used as a reference for the obtained measurements. Stimulation levels corresponded to a hearing level of 60 dB HL for frequencies between 250 and 6000 Hz. In addition, bone cement was used as a simulation for reactive bone growth. Results obtained in four heads indicate an improved power transmission of the transcutaneous actuator when implanted at the recommended position compared to the actuator of the percutaneous device on its respective recommended location when stimulating at an identical force level. A correlation was found between the promontory vibration and the actuator position, indicating that the same level of stimulation leads to higher promontory vibrations when the device is implanted closer to the ear canal. This is mainly reflected at frequencies higher than 1 kHz, where an increase was observed in both measurement modalities. At lower frequencies (<1 kHz), the power transmission is less influenced by the implant position and differences between the acquired responses are limited. In addition, when no rigid coupling to the skull is provided, power transfer losses of up to 30 dB can be expected.

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Section: Discussionmentioning

confidence: 99%

The Impact of Location and Device Coupling on the Performance of the Osia System Actuator

Fierens

Borgers

Putzeys

et al. 2022

BioMed Research International

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“…The system uses the same BI300 osseointegrated implant as other Cochlear TM devices with the OSI200 implant fixated to the osseointegrated BI300 screw [26]. Bone polishing may be required to ensure the transducer is in contact with the implant only and not surrounding bone, but drilling a bony well is not required [46]. This device uses a piezoelectric transducer which undergoes mechanical deformation when an electric voltage is applied [47].…”

Section: Active Transcutaneous Devicesmentioning

confidence: 99%

Review of Bone Conduction Hearing Devices

2021

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Bone conduction is an efficient pathway of sound transmission which can be harnessed to provide hearing amplification. Bone conduction hearing devices may be indicated when ear canal pathology precludes the use of a conventional hearing aid, as well as in cases of single-sided deafness. Several different technologies exist which transmit sound via bone conduction. Here, we will review the physiology of bone conduction, the indications for bone conduction amplification, and the specifics of currently available devices.

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“…An additional goal was to reduce attenuation of high frequency vibrations to achieve better gain and access to high frequency sounds than available in previous devices. Good outcomes of this device have recently been shown in adults (2). The aim of the present study was to assess the outcomes of this new BC device in adolescents.…”

mentioning

confidence: 95%

“…The OSSI system consists of an external sound processor (1) that captures and digitally processes sound. The sound processor then transmits power and digital information to the internal implant (2). Digital information in the internal implant converts the analog sound into an electric signal which is then transmitted to the actuator (4).…”

mentioning

confidence: 99%

First Generation Osseointegrated Steady State Implant Benefits in Children With Hearing Loss

Gordon

Papsin

Feness

et al. 2021

Otology &Amp; Neurotology

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Objective:To assess outcomes of a new Osseointegrated Steady State Implant (OSSI) for bone conduction in adolescents.Method:In an initial trial, 14 adolescents (14.5 years of age, SD = 2.22) were provided with an OSSI; unilateral OSSI (n = 13), bilateral OSSI in sequential surgeries (n = 1). Outcomes measured were surgical duration, complications, hearing thresholds, speech perception and self-reported hearing benefits using the Speech and Spatial Quality of Hearing Questionnaire.Results:The surgical times were mean 93.6 minutes (SD = 33.3). Surgery was slightly longer in three adolescents who required skin flap reduction (n = 1) or significant bone polishing (n = 2) (121.33 minutes, SD = 8.14). Adverse events occurred in two adolescents post-implant poor external device retention in one child requiring revision flap reduction and inflammation at the incision site due to magnet overuse in another. The “Digital Link Calibration” measure was a good proxy predictor of the strength of magnet required for external device adherence (p = 0.002). The OSSI increased audibility in the implanted ear by mean 31.48 dB HL (SE = 1.58). Aided thresholds were best at 1 kHz (mean 25.33 dB HL, SD = 22.60) and only slightly poorer at 3000 and 4000 Hz (estimate decrease = 8.33 dB HL, SE = 3.54), reflecting good auditory sensitivity even at high frequencies. Speech perception when using the new device alone was good (89.67%, SD = 7.84%) and self-reported hearing by participants and parents improved in all domains assessed by the Speech and Spatial Quality of Hearing Questionnaire (estimate = 1.90 points, SE = 0.25, p < 0.0001).Conclusion:The OSSI provides hearing benefits with surgical safety in a carefully selected cohort of adolescents.

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Multicenter Clinical Investigation of a New Active Osseointegrated Steady-State Implant System

Cited by 32 publications

References 31 publications

The Impact of Location and Device Coupling on the Performance of the Osia System Actuator

The Impact of Location and Device Coupling on the Performance of the Osia System Actuator

Review of Bone Conduction Hearing Devices

First Generation Osseointegrated Steady State Implant Benefits in Children With Hearing Loss

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