Otologics middle ear transducer™ ossicular stimulator: Performance results with varying degrees of sensorineural hearing loss

Jenkins, Herman A.; Niparko, John K.; Slattery, William H.; Neely, J. Gail; Fredrickson, John M.

doi:10.1080/00016480410016298

Cited by 83 publications

(87 citation statements)

References 2 publications

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“…The transducer of the fully implantable device was first attached to the body of the incus as previously reported for the MET semi-implantable system. Jenkins et al [2004] have shown that in general, the capability of the MET ossicular stimulator to provide appropriate gain as a function of the degree of hearing loss indicates that the device is a viable treatment for moderate to severe sensorineural hearing loss when attached to the ossicular chain, i.e. the body of the incus.…”

Section: Discussionmentioning

confidence: 99%

A Pilot Study of the Safety and Performance of the Otologics Fully Implantable Hearing Device: Transducing Sounds via the Round Window Membrane to the Inner Ear

et al. 2008

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Objectives: The safety and performance of the Otologics fully implantable hearing device were assessed in adult patients with mixed conductive and sensorineural hearing loss. Methods: The subcutaneous microphone of this fully implantable device picks up ambient sounds, converts them into an electrical signal, amplifies the signal according to the user’s needs, and sends it to an electromechanical transducer. The transducer tip is customized with a prosthesis in order to be in contact with the round window membrane and is protected by fascia; this translates the electrical signal into a mechanical motion that directly stimulates the round window membrane and enables the user to perceive sound. The implanted battery is recharged daily via an external charger and the user can turn the implant on and off as well as adjust the volume with a hand-held remote control. In this pilot study, 6 patients with mixed conductive and sensorineural hearing loss were implanted with the Otologics fully implantable hearing device. Pre- and postoperative air conduction, bone conduction, as well as aided and unaided thresholds and speech scores were measured. Results: No significant differences between preoperative and postoperative pure-tone averages were noted. Average improvement ranged from 19.16 to 35.8 dB of functional gain across audiometric frequencies with a mean of 26.17 ± 5.15 dB. Long-term average functional gain at 12 months was 20.83 ± 6.22 dB. Word recognition scores demonstrated significant differences between unaided and implant-aided conditions. Conclusions: Preliminary results of this trial of the Otologics fully implantable hearing device provide evidence that this fully implantable device is capable of efficiently transferring the sound to the inner ear via the round window membrane in patients with mixed hearing loss.

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Section: Discussionmentioning

confidence: 99%

A Pilot Study of the Safety and Performance of the Otologics Fully Implantable Hearing Device: Transducing Sounds via the Round Window Membrane to the Inner Ear

et al. 2008

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Section: Introductionmentioning

confidence: 99%

“…However, they are subject to limitations such as occlusion of the ear canal, chronic irritation, acoustic feedback, sound distortion and ear level limitations [Kasic and Fredrickson, 2001;Jenkins et al, 2004]. Recently, active middle ear implants (AMEI) have been developed to overcome these problems [Kasic and Fredrickson, 2001;Jenkins et al, 2004Jenkins et al, , 2007Jenkins et al, , 2008. The floating mass transducer of the Vibrant Soundbridge from Med-El (Innsbruck, Austria), the Middle Ear Transducer TM from Otologics LLC (Boulder, Colo., USA) and the Esteem 2 (Envoy Medical, St. Paul, Minn., USA) are three commercially available AMEI for the treatment of moderate-to-severe sensorineural hearing loss in adults [Kasic and Fredrickson, 2001;Sterkers et al, 2003;Jenkins et al, 2004Jenkins et al, , 2007Jenkins et al, , 2008; Barbara et al, 2009].…”

Section: Introductionmentioning

confidence: 99%

Round Window Membrane Implantation with an Active Middle Ear Implant: A Study of the Effects on the Performance of Round Window Exposure and Transducer Tip Diameter in Human Cadaveric Temporal Bones

Tringali

Koka²,

Devèze

et al. 2010

Audiol Neurotol

Self Cite

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Objectives: To assess the importance of 2 variables, transducer tip diameter and resection of the round window (RW) niche, affecting the optimization of the mechanical stimulation of the RW membrane with an active middle ear implant (AMEI). Materials and Methods: Ten temporal bones were prepared with combined atticotomy and facial recess approach to expose the RW. An AMEI stimulated the RW with 2 ball tip diameters (0.5 and 1.0 mm) before and after the resection of the bony rim of the RW niche. The RW drive performance, assessed by stapes velocities using laser Doppler velocimetry, was analyzed in 3 frequency ranges: low (0.25–1 kHz), medium (1–3 kHz) and high (3–8 kHz). Results: Driving the RW produced mean peak stapes velocities (H_EV) of 0.305 and 0.255 mm/s/V at 3.03 kHz, respectively, for the 1- and 0.5-mm tips, with the RW niche intact. Niche drilling increased the H_EV to 0.73 and 0.832 mm/s/V for the 1- and 0.5-mm tips, respectively. The tip diameter produced no difference in output at low and medium frequencies; however, the 0.5-mm tip was 5 and 6 dB better than the 1-mm tip at high frequencies before and after niche drilling, respectively. Drilling the niche significantly improved the output by 4 dB at high frequencies for the 1-mm tip, and by 6 and 10 dB in the medium- and high-frequency ranges for the 0.5-mm tip. Conclusion: The AMEI was able to successfully drive the RW membrane in cadaveric temporal bones using a classical facial recess approach. Stimulation of the RW membrane with an AMEI without drilling the niche is sufficient for successful hearing outputs. However, the resection of the bony rim of the RW niche significantly improved the RW stimulation at medium and higher frequencies. Drilling the niche enhances the exposure of the RW membrane and facilitates positioning the implant tip.

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“…Despite BAHA being recommended to the patient, he did not want to use BAHA because of cosmetic reasons. Active middle ear implants are safe and efficient in moderate to severe sensorineural hearing loss in adults [2] . The transducer of Carina can be coupled to an ossicular prosthesis or it can be placed on the round window [5][6][7] .…”

Section: Discussionmentioning

confidence: 99%

“…Active middle ear implants can be used in the presence of these drawbacks. Carina (Otologics) is a fully implantable active middle ear implant with an electromagnetic transducer, which can be coupled to ossicles or windows in the middle ear [2] . Herein we report a case in which the Carina transducer was coupled to the endosteum of the cochlea as a new method of application.…”

Section: Introductionmentioning

confidence: 99%

A Novel Way of Stimulation of the Inner Ear via Labyrinthotomy with Fully Implantable Active Middle Ear Implant, Carina

Bayazıt¹,

Tutar²,

Tutar³

et al. 2014

Int Adv Otol

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The aim of this case report is to demonstrate the effectiveness of Carina for the treatment of mixed hearing loss by stimulation of the inner ear via the endosteum of the cochlea.The left ear of a 55-year-old man with bilateral mixed hearing loss was implanted with Carina. Due to absence of middle ear ossicles and oval and round windows, the transducer was coupled with the endosteum of the cochlea. A significant improvement was observed in the pure tone average after Carina application. Carina and a conventional hearing aid yielded similar amplification in the low frequencies (250 Hz to 1 kHz). The functional gain with Carina was better than that with the conventional hearing aid in the middle (2 kHz) and high (4 and 6 kHz) frequencies, by 15dB, 5dB, and 25dB, respectively. Speech reception threshold in the free field was 80 dB HL without the hearing aid, 60 dB HL with the hearing aid, and 50 dB HL with Carina. Two-syllable speech discrimination scores increased to 40% and 56% in noise and quiet, respectively. According to International Outcome Inventory for Hearing Aids questionnaire, the patient scored 24 with the hearing aid and 32 with Carina.Stimulation of the inner ear with Carina though the endosteum of the cochlea seems to be an efficient and alternative way to amplify hearing.

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Otologics middle ear transducer™ ossicular stimulator: Performance results with varying degrees of sensorineural hearing loss

Abstract: The capability of the MET Ossicular Stimulator to provide appropriate gain as a function of degree of hearing loss indicates that the device is a viable treatment for moderate to severe sensorineural hearing loss in adults.

Cited by 83 publications

References 2 publications

A Pilot Study of the Safety and Performance of the Otologics Fully Implantable Hearing Device: Transducing Sounds via the Round Window Membrane to the Inner Ear

A Pilot Study of the Safety and Performance of the Otologics Fully Implantable Hearing Device: Transducing Sounds via the Round Window Membrane to the Inner Ear

Round Window Membrane Implantation with an Active Middle Ear Implant: A Study of the Effects on the Performance of Round Window Exposure and Transducer Tip Diameter in Human Cadaveric Temporal Bones

A Novel Way of Stimulation of the Inner Ear via Labyrinthotomy with Fully Implantable Active Middle Ear Implant, Carina

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