SOURCES SOUGHT
A -- Feasibility of an Intraneural Auditory Prosthesis
- Notice Date
- 12/18/2008
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- National Institutes of HealthOD - Office of Logistics andAcquisition OperationsBethesdaMD20892-7511
- ZIP Code
- 20892-7511
- Solicitation Number
- NIHDC2009007
- Response Due
- 1/2/2009
- Archive Date
- 2/1/2009
- Point of Contact
- DAVIS, DEREK +1 301 496 8505, davisd3@mail.nih.gov<br />
- Small Business Set-Aside
- N/A
- Description
- The National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH) is seeking small businesses that possess the ability to study the feasibility of intraneural auditory nerve stimulating electrode arrays, utilize chronic neurophysiological tests to evaluate safety and efficacy in an animal model, evaluate any possible histopathology resulting from implantation or stimulation of the tissue, and make a recommendations for development of an intraneural electrode array for use in hearing impaired patients. This is a Sources Sought Notice used to identify qualified small businesses including 8(a), HUBZone, Women Owned Small business, Small disadvantaged Business, and/or Service-Disabled Veteran-owned business concerns that are interested in and capable of performing the work described in the Statement of Work (SOW) below. This is not a Request for Proposals (RFP) and does not commit the Government to award a contract now or in the future. No RFP is available at this time. Small business concerns that believe they possess the capabilities necessary to undertake the work described in the SOW should respond to this notice. Potential offerors should then submit one (1) copy of their capability statement, not to exceed 20 pages, to the attention of: Derek Davis, Contract Specialist, OD/OLAO, via email to Derek.Davis@nih.gov. CAPABILITY STATEMENTS MUST BE RECEIVED NO LATER THAN 2:00 PM EST, JANUARY 2, 2009. The North American Industry Classification System (NAICS) Code for this requirement is 541712. Questions should be addressed to Silver Jones, Contracting Officer, at (301) 496-8504 or email at Silver.Jones@nih.gov. It is anticipated that a cost reimbursement, completion type contract will be awarded. The successful offeror shall be responsible for furnishing all laboratory and office space and facilities necessary for work under this requirement; access to Government-controlled property will not be provided. Any proprietary information submitted in response to this sources sought notice should be marked. This is only a sources sought notice, and no solicitation is available at this time. Please see the SOW below for further details. Statement of Work: Background:Cochlear implants have been widely used to restore a sense of sound to users that were profoundly deaf, with more than 100,000 devices in use worldwide. Commercial implants operate by electrical stimulation of surviving portions of the auditory nerve through an electrode array placed in the scala tympani of the cochlea. The major limitation of this approach, however, is the broad spread of neural excitation that is derived from electrodes placed within the cochlea. Significant gains in auditory ability are likely to be obtained by increasing the number of spectral channels and dynamic range of each stimulating electrode. Recent animal studies utilizing a novel intraneural stimulating electrode have produced clear evidence that robust and frequency-specific responses can be driven through an intraneural implant design. This approach could also provide a means to stimulate the auditory nerve of patients with cochlear pathologies that preclude insertion of an electrode array into the scala tympani. All of these features are likely to provide important gains in user perception if a device safe for human use can be constructed around this concept. Now that acute animal studies have established the restricted nature of excitation, chronic animal studies are needed to investigate safety issues. Interactions with surgical experts and medical device designers are required to develop this concept into a device optimized for use in patients with hearing loss. Objective:Design intraneural electrode arrays for use in a multichannel prostheses that can be inserted directly into the human auditory nerve and perform animal studies that assess safety and efficacy of this approach. Work to be performed:A. Utilize the cat (Felis catus) auditory nerve as the animal model of the human auditory nerve during its course from the modiolus to the cochlear nucleus. Previous research for development of neural prostheses for auditory neural pathways has provided a significant body of scientific literature describing sound and electrical evoked activity in this animal. B. Design appropriate electrode configurations for electrical stimulation of the auditory nerve. Multiple stimulation sites shall be provided on each electrode shank, since this design maximizes the number of electrode sites across electrode insertions. Additional configurations of stimulating electrodes and novel forms of neural stimulation beyond electrical currents can be proposed to add merit to the proposal. C. Select at least two implantation sites within the animal models auditory nerve that mimic candidate locations for chronic electrode placement in human subjects. Additional implantation sites may be utilized to facilitate access to the nerve tissue for later histological analysis. Interactions with surgical experts and implant fabricators are expected to develop optimal approaches for use of this technology in patient populations with hearing loss. D. Utilize multichannel electrode arrays with recording sites distributed across the central nucleus of the inferior colliculus (CNIC) to record single and multiple unit activity as driven by electrical stimulation through the intraneural electrode array. Perform acute and chronic neurophysiological animal studies to quantify functional capabilities and safety concerns of the proposed stimulating electrode designs and placement strategies. 1. Determine the ability of intraneural electrodes to stimulate restricted populations of auditory nerve fibers at low stimulus levels.2. Determine the approximate number of fibers activated as a function of stimulus level from neural thresholds up to maximal levels that can be safely applied to nerve tissue during chronic use.3. Quantify differences in the neural populations activated based on the placement of the stimulating sites in different regions of the nerve.4. Quantify temporal features of the electrically driven neural response, and compare these results to the capabilities needed to provide enhanced benefit from a neural prosthesis. 5. Assess capabilities for simultaneous stimulation of more than one electrode to provide enhanced benefits from a neural prosthesis.6. Additional studies that develop and assess novel capabilities available from intraneural stimulation can be proposed to add merit to the proposal. E. Chronic studies shall be performed in the animal model to provide preclinical data and address any safety concerns arising from use of an intraneural electrode array. At a minimum, these studies shall include chronic stimulation of a statistically appropriate number of animals at suprathreshold levels for periods of at least 60 hours per week over a two month period. Where advantageous, this activity should make use of hardware and software developed under the NIDCD contract, Open Architecture Research Interface for Cochlear Implants. F. Upon completion of chronic stimulation, histopathologic assessment of the auditory nerve tissue near the electrode contacts shall be conducted to determine the presence of tissue damage due to:1. passive implantation with non-stimulated control electrodes.2. chronic stimulation at suprathreshold levels. G. Upon analysis of the results from the animal studies, determine the safety and effectiveness of a chronic intraneural electrode array(s) in the animal model. Suggest further studies for the development of a safe and effective intraneural auditory prosthesis for human use. H. Technological Resource Sharing. The Contractor shall provide engineering documentation for technological resources developed in the course of performing the project, such as electronic circuit schematics, printed circuit board layout specifications, and software source code. I. Publish research data in peer-reviewed scientific journals. Data acquired during performance of the project shall be fully analyzed to determine important trends and subsequently published in the peer-reviewed literature. At least one submission for peer-review in a scientific journal is required on an annual basis to provide a timely review of the ongoing research and wide dissemination of the results. Required Travel:The Contractor shall travel to national scientific meetings on an annual basis to present recent findings of the studies performed under the contract in conjunction with PIs from other NIDCD Neural Prosthesis Development awards. The semiannual Conference on Implantable Auditory Prostheses and the annual meeting of the Association for Research in Otolaryngology are typically candidates for these meetings. Offerors should estimate two persons traveling for four days per year. Deliverables:In addition to those reports required by the other terms of this contract, the Contractor shall prepare and submit to the Government the following reports/deliverables in the manner and number specified below: A.Quarterly Progress ReportThe Quarterly Progress Report shall consist of an abstract summarizing activity followed by a brief description of the work performed during the previous quarter and the anticipated work plan for the coming quarter. The first reporting period consists of the first full quarter of performance, including any fractional part of the initial month. Thereafter, the reporting period shall consist of three full calendar months. The report shall be submitted within 15 calendar days of the end of each quarter of the contract. A Quarterly Report is not due for the final quarterly period of the contract. One copy of each Quarterly Progress Report shall be submitted in the PDF electronic document format to the Project Officer and to the Contracting Officer by e-mail; addresses will be provided at the time of the award. Proprietary information may be withheld, after approval by the Project Officer. B. Final ReportThe Final Report shall briefly summarize the findings of the studies performed under the contract and shall include both positive and negative results; it should also provide recommendations for future research and development in the area. Research results from the last quarter of the contract should be included. Articles published, or submitted for publication, during the contract period should be listed and reprints should be included as an appendix. One copy of the Final Report shall be submitted to the Project Officer and to the Contracting Officer by e-mail (addresses will be provided at the time of the award) in the PDF document format on or before the expiration date of the contract. The Final Report will be made available to the public through the NIDCD Neural Prosthesis Development Web page (www.nidcd.nih.gov/npp). Proprietary information may be withheld, after approval by the Project Officer.
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