Our technology will
advance hearing solutions.

Our technology will
advance hearing solutions.

The Market

In a market where cochlear implants (“CI”) have traditionally been used to treat patients with severe to complete hearing loss (1.2 million people in the US), recent advances have now made the CI a treatment option for people with moderate hearing loss (as many as 6.3 million people in the US). Our enabling technologies are poised to allow CI companies and surgeons to successfully expand access to hearing solutions for this under-served patient population.

Current clinical outcomes for patients receiving hearing preservation cochlear implants can vary significantly among surgeon experience, implant centers, and electrode types. Multiple studies have indicated between 15% and 50% of hearing preservation implant recipients may experience additional loss of their natural hearing following surgery. [4, 5, 6, 7, 8]

  • Additional loss of their natural hearing – up to 50%

million people with disabling hearing loss (US)

million patients with severe/complete hearing loss served by CI (US)

million potential patients with moderate hearing loss (US)

recent research identifies impact of insertion

A number of researchers have identified consistency of insertion speed and force as a key contributor to the success of the procedure and a primary element in preservation of hearing loss. The general conclusion is that a slow, constant insertion speed is essential in minimizing the intraoperative damage to the cochlea and the successful patient hearing preservation.

UNDERSTANDING THE IMPACT OF INSERTION FORCE

Insertion speed relates to insertion force

Literature supports the connection between high insertion speed and the resulting increase of resultant forces, with the recommendation that CI surgeons should use low and stable speeds during insertion of the electrode. [1]

Increased forces correlate with inner ear structure damage

During electrode insertion and advancement, high forces are shown to correlate with the level of structure damage inside the cochlea. Importantly, as the electrode travels through high-risk regions for peak forces, corresponding damage such as basilar membrane lesion or translocation can be recorded. [2]

Insertion speed as it relates to function

Conclusions are routinely drawn in the literature around how slow electrode insertion speeds relate to positive results while reducing insertion resistance and thus preserving residual hearing and function. [3]

Products Under Development

iotaSOFT

An open platform robotic-assisted system that aims to decrease surgical variability by controlling the speed and acceleration of electrode insertion.

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Precision cochlear implant insertion

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Multiple electrode compatibility

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Decrease occurrence of pressure spikes during insertion

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Disposable single-use module; reusable control system

iotaPROGRESS

An implantable robotic-assisted control system that allows for precise intra-operative implantation, and enables post-surgical re-positioning in a clinic office to account for further hearing loss.

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Robotic-assisted controlled insertion

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Implantable system for post-surgical re-positioning

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Multiple electrode compatibility

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Non-surgical adjustments to account for post-surgical hearing loss

iotaPROGRESS

An implantable robotic-assisted control system that allows for precise intra-operative implantation, and enables post-surgical re-positioning in a clinic office to account for further hearing loss.

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Robotic-assisted controlled insertion

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Implantable system for post-surgical re-positioning

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Multiple electrode compatibility

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Non-surgical adjustments to account for post-surgical hearing loss

iotaPRECISION

Cochlear implant with a fully-integrated position control system to allow for enhanced hearing preservation via precise implantation and in-office electrode re-positioning.

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Fully-integrated system for advanced hearing preservation

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Robotic-controlled electrode insertion

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Post-surgical in-office electrode repositioning

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Low-profile fully integrated insertion, positioning, and cochlear implant system

NOTE: Investigational device limited by US law to investigational use only. This device is not yet cleared for use in humans.

US and International patents pending.

[1] Kontorinis G, Lenarz T, Stöver T, Paasche G. “Impact of the insertion speed of cochlear implant electrodes on the insertion forces.” Otology & Neurotology, 2011 Jun 32(4):565-70.

[2] De Seta D, Torres R, Russo FY, Ferrary E, Kazmitcheff G, Heymann D, Amiaud J, Sterkers O, Bernardeschi D, Nguyen Y. “Damage to inner ear structure during cochlear implantation: Correlation between insertion force and radio-histological findings in temporal bone specimens.” Hearing Research. 2017 Feb 344:90-97.

[3] Rajan GP, Kontorinis G, Kuthubutheen J. “The effects of insertion speed on inner ear function during cochlear implantation: a comparison study.” Audiology & Neuro-otology. 2013 18(1):17-22.

[4] Gifford, R.H., et al., 2013. “Cochlear implantation with hearing preservation yields significant benefit for speech recognition in complex listening environments.” Ear Hear. 34 (4), 413e425.

[5] Reiss, L.A.J., Turner, C.W., Karsten, S.A., Erenberg, S.R., Taylor, J., Gantz, B.J., 2012b. “Consonant recognition as a function of the number of stimulation channels in the hybrid short-electrode cochlear implant.” J. Acoust. Soc. Am. 132 (5), 3406e3412.

[6] Van Abel, K.M., et al., 2015. “Hearing preservation among patients undergoing cochlear implantation.” Otol. Neurotol. Off. Publ. Am. Otol. Soc. Am. Neurotol. Soc. Eur. Acad. Otol. Neurotol. 36 (3), 416e421.

[7] Lenarz, T., et al., 2013. “European multi-centre study of the nucleus hybrid L24 cochlear implant.” Int. J. Audiol. 52 (12), 838e848.

[8] Adunka, O.F., et al., 2013. “Hearing preservation and speech perception outcomes with electric-acoustic stimulation after 12 months of listening experience.” Laryngoscope 123 (10), 2509e2515.