A Steadier Hand: The First Human Clinical Trial of a Single-Use Robotic-Assisted Surgical Device for Cochlear Implant Electrode Array Insertion

Gantz, Jay A.; Gantz, Bruce J.; Kaufmann, Christopher R.; Henslee, Allan M.; Dunn, Camille; Hua, Xiaoyang; Hansen, Marlan R.

doi:10.1097/mao.0000000000003749

Cited by 13 publications

(14 citation statements)

References 36 publications

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“…The clinical utility of the iotaSOFT single-use robotics-assisted insertion device in a CI patient cohort has previously been described (11). The system enables the surgeon to advance and retract an EA in a steady tremor-free fashion, at speeds as slow as 0.1 mm/s, and to pause electrode movement.…”

Section: Discussionmentioning

confidence: 99%

“…The electrode can be advanced/retracted at a speed set between 0.1 and 1 mm/s at 0.1 mm/s intervals, stopped, or reversed. Intraoperative device setup adds an average of less than 1 minute to operative time (11). The EAs used in this study included the Flex 24/26 (MED-EL Corp., Durham, NC) and HiRes Ultra Slim J (Advanced Bionics [AB] LLC, Valencia, CA).…”

Section: Robotics-assisted Insertion and Operative Protocolmentioning

confidence: 99%

“…However, these outcomes are not achieved in all hearing preservation surgeries. Despite careful manual insertion technique, roughly 50% of hearing preservation CI recipients experience additional loss of greater than 10 dB, and 10% to 20% will lose all residual function (4,(11)(12)(13)(14). An inherent issue with manual electrode array (EA) insertion is that the minimum force required to damage the cochlear lies below the threshold of human perception (11,15).…”

Section: Introductionmentioning

confidence: 99%

“…Despite careful manual insertion technique, roughly 50% of hearing preservation CI recipients experience additional loss of greater than 10 dB, and 10% to 20% will lose all residual function (4,(11)(12)(13)(14). An inherent issue with manual electrode array (EA) insertion is that the minimum force required to damage the cochlear lies below the threshold of human perception (11,15). Manual insertion cannot be sustained at a speed or constant rate that minimizes cochlear damage, increasing the likelihood of compromising residual acoustic (16)(17)(18)(19)(20).…”

Section: Introductionmentioning

confidence: 99%

“…Robotics-assisted EA insertion is an emerging technique in hearing preservation CI that can overcome the limitations of manual insertion, with studies suggesting lower rates of translocation and cochlear trauma (7,(21)(22)(23)(24). Our group has previously described the clinical safety and utility of a single-use robotic-assisted CI EA insertion device that can delicately insert an array at constant speed as low as 0.1 mm/s (11). Steady and slow insertion may also enhance feedback to the surgeon by facilitating intraoperative physiological measures of cochlear activity such as electrocochleography (ECochG).…”

Section: Introductionmentioning

confidence: 99%

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Combining Intraoperative Electrocochleography with Robotics-Assisted Electrode Array Insertion

Kashani,

Kocharyan,

Bennion

et al. 2024

Otol Neurotol

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Objective To describe the use of robotics-assisted electrode array (EA) insertion combined with intraoperative electrocochleography (ECochG) in hearing preservation cochlear implant surgery. Study Design Prospective, single-arm, open-label study. Setting All procedures and data collection were performed at a single tertiary referral center. Patients Twenty-one postlingually deaf adult subjects meeting Food and Drug Administration indication criteria for cochlear implantation with residual acoustic hearing defined as thresholds no worse than 65 dB at 125, 250, and 500 Hz. Intervention All patients underwent standard-of-care unilateral cochlear implant surgery using a single-use robotics-assisted EA insertion device and concurrent intraoperative ECochG. Main Outcome Measures Postoperative pure-tone average over 125, 250, and 500 Hz measured at initial activation and subsequent intervals up to 1 year afterward. Results Twenty-two EAs were implanted with a single-use robotics-assisted insertion device and simultaneous intraoperative ECochG. Fine control over robotic insertion kinetics could be applied in response to changes in ECochG signal. Patients had stable pure-tone averages after activation with normal impedance and neural telemetry responses. Conclusions Combining robotics-assisted EA insertion with intraoperative ECochG is a feasible technique when performing hearing preservation implant surgery. This combined approach may provide the surgeon a means to overcome the limitations of manual insertion and respond to cochlear feedback in real-time.

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Section: Discussionmentioning

confidence: 99%

Section: Robotics-assisted Insertion and Operative Protocolmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Combining Intraoperative Electrocochleography with Robotics-Assisted Electrode Array Insertion

Kashani,

Kocharyan,

Bennion

et al. 2024

Otol Neurotol

Self Cite

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Metronome-guided cochlear implantation for slower and smoother insertions of lateral wall electrodes

Wimmer,

de Oliveira,

Breitsprecher

et al. 2024

Eur Arch Otorhinolaryngol

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Introduction Achieving a slow and smooth electrode array insertion is paramount for preserving structural and functional integrity during cochlear implantation. This controlled study evaluates the efficacy of a metronome-guided insertion technique in enhancing the smoothness and speed of electrode array insertions. Methods In a prospective cohort study, patients undergoing cochlear implant surgery between 2022 and 2023 with lateral wall electrode arrays were included. Metronome guidance was delivered through an acoustic signal via headphones during electrode array insertion in cochlear implantation and compared to a control group without metronome-guidance. Results In total, 37 cases were evaluated, including 25 conventional insertions and 12 metronome-guided insertions. The results indicate that metronome-guided insertions were significantly slower (− 0.46 mm/s; p < 0.001) without extending the overall procedure time. This can be attributed to fewer paused sections observed in the metronome-guided technique. Moreover, metronome-guided insertions exhibited superior performance in terms of insertion smoothness and a reduced number of re-gripping events. Conclusions The findings support the recommendation for the systematic application of metronome guidance in the manual insertion of cochlear implant electrode arrays, emphasizing its potential to optimize surgical outcomes.

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Objective evaluation, using computed tomography, of round window access for cochlear implantation

Radomska,

Mielnik,

Gostyński

et al. 2024

Eur Arch Otorhinolaryngol

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Objective The aim of this study was to determine optimal radiological parameters for assessment of the round window approach in cochlear implantation surgery. Materials and methods Patients undergoing cochlear implantation at the Department of Otolaryngology in Szczecin, between 2015 and 2022 inclusive, were eligible for the study. Radiological assessments were performed according to eight parameters (seven proposed in the literature) and visibility clinical assessments were made intra-operatively on a scale of 1 to 5 (1 - not visible, 5 - fully visible). Visibility assessments of the round window niche (RWN) and round window membrane (RWM) allowed the difference (RWN minus RWM) to be used as a clinical assessment of the size of the overhang over the round window. Results Computed tomography images of 57 ears from 52 patients were analyzed in terms of round window access. The study group included 26 females and 26 males, ranging in age from 1 year to 80 years, with a median age of 41 years. In clinical assessment, round window visibility was rated as 5, after removal of the bone overhang, in 69% of patients. Cochlear access through the round window was achieved in 39 (68%) cases, extended access through the round window in 13 (23%) cases and cochleostomy was performed in 5 (9%) cases. Statistically significant ordinal correlations with round-window access were found using one parameter from the literature (Chen_Angle) and from our proposal (RWM_prediction). From parameters describing the bone overhang of the round window, positive correlations (using Kendall rank tests) were found using parameters from the literature (Sarafraz_OH and Mehanna_OH). Conclusions Radiological measurements describing access to the round window which determine the angle based on the anatomy of the posterior wall of the auditory canal and the position of the facial nerve were found to be of the highest value. Clinical relevance statement In the future, the use of algorithms for computed tomography evaluation and robot-assisted surgery will require parameters for assessing round window access, for surgery planning and choice of electrode. The parameters proposed by various authors are summarized, allowing researchers to assess their usefulness in further clinical practice.

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A Steadier Hand: The First Human Clinical Trial of a Single-Use Robotic-Assisted Surgical Device for Cochlear Implant Electrode Array Insertion

Cited by 13 publications

References 36 publications

Combining Intraoperative Electrocochleography with Robotics-Assisted Electrode Array Insertion

Combining Intraoperative Electrocochleography with Robotics-Assisted Electrode Array Insertion

Metronome-guided cochlear implantation for slower and smoother insertions of lateral wall electrodes

Objective evaluation, using computed tomography, of round window access for cochlear implantation

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