Award Abstract # 1621920
SBIR Phase I: Implantable Robotic System for Hearing Loss Treatment

NSF Org: TI
Translational Impacts
Recipient: IOTAMOTION, INC.
Initial Amendment Date: June 20, 2016
Latest Amendment Date: June 20, 2016
Award Number: 1621920
Award Instrument: Standard Grant
Program Manager: Muralidharan Nair
TI
 Translational Impacts
TIP
 Dir for Tech, Innovation, & Partnerships
Start Date: July 1, 2016
End Date: June 30, 2017 (Estimated)
Total Intended Award Amount: $225,000.00
Total Awarded Amount to Date: $225,000.00
Funds Obligated to Date: FY 2016 = $225,000.00
History of Investigator:
  • Allan Henslee (Principal Investigator)
    allan@iotamotion.com
Recipient Sponsored Research Office: IOTAMOTION, INC.
14 S CLINTON ST
IOWA CITY
IA  US  52240-3912
(361)688-4140
Sponsor Congressional District: 01
Primary Place of Performance: IOTAMOTION, INC.
2500 Crosspark Rd
Coralville
IA  US  52241-4710
Primary Place of Performance
Congressional District:
01
Unique Entity Identifier (UEI): HVTWTNGRTV88
Parent UEI:
NSF Program(s): SBIR Phase I
Primary Program Source: 01001617DB NSF RESEARCH & RELATED ACTIVIT
Program Reference Code(s): 5371, 6840, 8034, 8035, 9150, HPCC
Program Element Code(s): 5371
Award Agency Code: 4900
Fund Agency Code: 4900
Assistance Listing Number(s): 47.041

ABSTRACT

The broader impact/commercial potential of this project will be improved capabilities of current hearing assistive cochlear implants through the development of a miniature implantable robotic system. It will enable many more patients with hearing loss to retain their hearing capacity much longer over their lifetimes. Hearing loss has a significant impact on physical and mental health, education, employment, and overall quality of life, and has been linked to an increased risk of dementia and feelings of depression, frustration, anxiety, and social isolation. 53 million people have severe-to-profound hearing loss and are eligible for traditional cochlear implants, but there are an additional 300 million with partial-to-moderate disabling hearing loss who are not eligible for a traditional implant and do not significantly benefit from other hearing assistive devices alone. The development of this technology will enable a much wider population of those with hearing loss to receive the benefits of a cochlear implant, using a novel wireless control and the added convenience of personalized hearing loss treatment regimens. This technology will also facilitate commercial opportunities for use of the implantable robotic system in other applications where an implantable electrode/wire requires precise and dynamic remote position adjustments.

This Small Business Innovation Research (SBIR) Phase I project will design, develop and test a prototype of an implantable robotic system that wirelessly optimizes cochlear implant function and enables clinician adjustments as patient hearing deteriorates. Though traditional cochlear implants are used to treat severe-profound hearing loss, recent advances in hearing preservation technologies have allowed those with partial hearing loss, such as from noise exposure or aging, to benefit from cochlear implants. Unfortunately, clinical trials have found that more than 50% of these recipients experience continued hearing deterioration after cochlear implantation. Treatment options are limited to additional surgery for electrode replacement or living with limited hearing because the implants cannot be adjusted. This research is focused on developing an implantable robotic control system that will enable cochlear implants to dynamically adjust to post-surgical hearing decline without the need for additional surgery. In Phase I, individual components will be assembled into a functioning implantable robotic system that meets design and surgical size requirements to effectively move an electrode within a human cadaveric cochlea model. Anticipated results will include a prototype that has a novel micromechanical system for electrode adjustments, wireless communications for external control, and safe transcutaneous power.

PROJECT OUTCOMES REPORT

Disclaimer

This Project Outcomes Report for the General Public is displayed verbatim as submitted by the Principal Investigator (PI) for this award. Any opinions, findings, and conclusions or recommendations expressed in this Report are those of the PI and do not necessarily reflect the views of the National Science Foundation; NSF has not approved or endorsed its content.

In recent decades, the cochlear implant (CI) has revolutionized the treatment of patients who suffer from moderate to severe hearing loss, a population of approximately 360 million worldwide.  These devices are placed deep in the inner ear, where the implant directly stimulates the auditory nerve to restore lost hearing. However, for patients who undergo hearing preservation CI surgery in which the implant compliments a portion of the remaining natural hearing, up to 50% of patients experience additional hearing loss following surgery with a viable solution yet to be identified.  Additionally, each patient’s hearing loss pattern is unique and progresses differently during their lifetime.  Therefore, treatment using CIs needs to be customizable and adjustable over time to optimize hearing quality and allow patients the full appreciation of complex sounds such as music or a conversation – those most important to high quality of life.  

iotaMotion is developing a fully implantable accessory to the cochlear implant that enables remote implant adjustments to address post-surgical hearing loss.  Our proprietary technology will personalize the treatment regimen for CI recipients.  The device will control the insertion of the CI to reduce surgical trauma as well as enable novel in–office hearing optimization as an individual's hearing evolves without the need for repeat surgery. The device will facilitate remote non-surgical electrode adjustment for improved quality of life, optimize hearing quality through individualized "best fit", and expand CI patient candidacy range and available market.

The goals of this project were to: (1) demonstrate the technical feasibility of iotaMotion’s device with a miniaturized, fully functional prototype; (2) evaluate the prototype technical feasibility in a human cadaveric surgical model; and (3) determine the manufacturing feasibility of the proposed system.  In task 1, the benchtop model of the device was translated into a fully functional prototype.  Individual components went through several design iterations and eventually were sourced and assembled into miniaturized prototypes for testing.  The prototypes were characterized in a benchtop setting to evaluate their effectiveness in controlling electrode insertions in both 3D-printed phantom cochleae and human cadaveric cochleae.  Insertions were also performed manually to represent the current gold standard in surgical technique.  The results showed that the device consistently produces significantly favorable results when compared to manual insertions.  In task 2, the prototype was evaluated for feasibility in a human cadaver head.  Under the guidance of our surgical advisor, the device was implanted as envisioned in a typical surgery and images were taken following wound closure.  The device was then used at a later point in time to further advance the electrode thus providing strong evidence for our proof of concept.  Lastly, in task 3, the current bill of materials was finalized including costs and a manufacturing plan was drafted. 

The work completed by this federal funding opportunity has greatly advanced the state of technology that will eventually be available to cochlear implant recipients.  Future work will include further development of the device with respect to manufacturing and regulatory compliance.  iotaMotion will then advance to in vivo studies and regulatory submission to obtain market approval as rapidly as possible.


Last Modified: 07/24/2017
Modified by: Allan Henslee

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