HEARING Frequently Asked Questions

Yes, you may submit (and be awarded as) the Prime PI on ONE (1) proposal and a sub-proposer on TWO (2) other proposals. You may not participate in research and development activities for more than three (3) proposals. You can provide an agent/device for more than two (2) teams, as long as there are no development efforts for any teams past two (2). At the full proposal stage, ARPA-H will not compensate performers twice for duplication of efforts. 

Yes, two separate teams from the same institution may submit a solution summary and a proposal to the same program.  Proposers who submit a Solution Summary may submit one (1) full proposal as the Prime awardee but may also be a sub-awardee on two (2) additional proposals. At the full proposal stage, ARPA-H will not compensate performers twice for duplication of efforts. If both proposals are approved, a performer can be a sub on a maximum of three (3) proposals as long as their contribution to each effort is novel to each proposal. 

Teams can have participants from industry or academia; however, federal entities are not allowed as prime or subawardees. You may collaborate with federal partners through a separate agreement. 

Yes, you may budget for work with a CRO. 

No, but be sure to include detailed budget information for each institution as per the ISO and include in your proposal a program management structure that explains how the teams will be coordinated and make meaningful contributions. 

No, there will be ONE (1) PI, the rest will be Co-Investigators. 

No, you must utilize the HEARING teaming page to find potential teammates or collaborators. We also encourage you to attend Proposer’s Day and network with fellow attendees to meet potential teammates. 

There are no specific requirements regarding tenure, and so a junior faculty member would be acceptable as Prime PI with demonstrated relevant experience and expertise. 

Restoring hearing loss cannot be achieved through a single approach or by one team alone. Collaboration among performer teams is encouraged to support the program’s success. The HEARING program team sees strong opportunities for collaboration in areas such as patient neural-auditory datasets and experimental approaches, insights related to auditory clinical assessments, and end-user feedback and form-factor design. Proposers are encouraged to identify additional opportunities to collaborate with other performer teams.

Solution summaries or proposals that have been written using generative AI will be considered non-conforming and will not be evaluated.  

During the source selection process, we are unable to discuss concepts that a potential applicant is submitting to the ISO. At this time, we will not be holding virtual side bars. If your Solution Summary is graded encouraged to submit a full proposal, you will have the opportunity to have a feedback call with the HEARING Team prior to submitting a full proposal. 

We want to see enough preliminary data to understand your capability of doing what you are proposing, but it would be highly reasonable to make multiple attempts or test multiple theories.  

The program team encourages a “multiple shots on goal” comprehensive experimental approach to account for a variety of possible approaches to the sensor and/or delivery device. If a complete change in the experimental approach is needed, you will be asked to communicate that with the HEARING team and justify the modifications.  

We are interested in patients with bilateral hearing loss as detailed in the ISO. 

No, we have no preference for animal models utilized as long as they mimic the human condition

In vitro evaluation for interim technologies is acceptable in Phase 1 and Phase 2. However, end of Phase metrics require animal and/or human studies, as relevant to TAs 1-3 and detailed in the ISO. 

We will entertain all approaches that are proposed, as long as they fit within the TA guidelines and can be used to satisfy the metrics proposed in the ISO. 

Yes, you must develop and validate your BCI algorithms in patient populations undergoing neurosurgical/BCI procedures or comparable, as outlined in the ISO.

There are no specific guidelines for selecting animal models. However, chosen models should be able to perform the relevant behavioral tasks needed to validate device performance at the end of Phase 1 and Phase 2, and they must be suitable for use in pre‑clinical regulatory studies. 

TA1 devices must be capable of safe passage through the selected delivery procedure and have sufficient surface area coverage to interface with key auditory cortical regions.  TA2 devices must be developed in a form factor that is not a burden to the daily living activities of the patient. For example, hats, helmets, headbands, and similar wearables are considered noncompliant. In contrast, form factors such as glasses, hearing aid– or external processor for cochlear implant–like devices, and armbands are considered compliant. 

Interim technologies may be delivered via surgical delivery through the cranium. However, delivery without a craniotomy (or similar procedures such as small burr holes or millimeter-scale access) must be demonstrated to meet Phase 2 and Phase 3 metrics as detailed in the ISO. 

Yes, the ISO specifies that we will require a failsafe in place in the event that connectivity is lost. 

Performers will be expected to manage their own engagements and comply with FDA regulations. 

HEARING has three Phases, and not all offerors are guaranteed to continue to subsequent phases. However, the metrics are not necessarily rigid Go/No-Go criteria, and instead are used to help make decisions about whether sufficient progress has been made. In other words, whether a performer is kept in the program will depend on the state of the technical program and how much progress has been made. 

Yes, absolutely, provided you are meeting/exceeding all technical metrics and guidelines. 

We are open to other approaches that would define success in each TA as long as they are a logical fit to satisfy the TA. 

Yes, the ISO specifies that a solution summary and proposal should address all three TAs in the HEARING Program. Teams that do not address all three TAs may not be considered. 

Non-invasive recording and stimulation technical approaches (e.g. EEG or transcranial ultrasound) are acceptable as long as they meet the technical and form-factor requirements outlined within the HEARING ISO. 

Our goal is to restore a patient’s ability to perceive speech in noisy environments, surpassing the capabilities of today’s state‑of‑the‑art technologies. Non‑auditory cortical interfacing approaches must be supported by strong evidence and clear justification demonstrating their potential to meet the program’s requirements for minimally invasive delivery, wireless power and data transmission, and robust recording and stimulation capabilities necessary for restoring hearing.

The HEARING device is also intended to be available to a wide range of hearing loss patients, including those that may have a damaged auditory nerve. Proposed solutions are expected to be highly novel and must deliver capabilities that current hearing‑restorative technologies cannot achieve. Further, proposals should outline plans for improved separation of speech from noise in mild to moderate hearing loss, not just in severe and profound hearing loss. 

The HEARING Program is designed for performers who view the FDA as a partner, where routine interactions during performance will be essential for moving technologies on the right pathway to meet the program’s goals. 

Yes! Two combinations of devices can be used for as long as they meet the requirements as outlined in the ISO. 

We recognize that many factors can influence the restoration of speech‑in‑noise perception. We welcome any approach that is valid, relevant, and capable of reliably assessing a meaningful improvement in a patient’s ability to hear speech in noise, as outlined in the program ISO. 

We believe that achieving the restoration of sound representations in the auditory cortex will require the level of spatial resolution specified in the ISO. However, if you can provide strong evidence demonstrating that your approach can meet the program’s goals without requiring such high spatial resolution, we welcome that justification in your solution summary and full proposal. 

Generally, the government does not take ownership of intellectual property produced under awards. 

The Other Transaction Agreement (OTA) is flexible, and IP will be subject to negotiations between the proposer and ARPA-H. 

At minimum, ARPA-H wants to ensure that IP restrictions do not keep breakthrough technologies from the people who can benefit from those technologies. 

Proposers are encouraged to propose a realistic, justifiable, comprehensive, and reasonable budget that aligns with the proposed solution. The proposed budget should align with the technical scope. No budget ceiling has been established. ​ 

We are not able to provide budgetary details for HEARING or a target number for your budget.​ 

ARPA-H discourages strategies such as using only junior staff or proposing only low-risk ideas to cut costs. 

Since 1990, Congress has legislatively mandated a limitation on direct salary for individuals under NIH grant and cooperative agreement awards. The Consolidated Appropriations Act, 2024 (Public Law 117-328) restricts the amount of direct salary to Executive Level II of the Federal Executive pay scale. This means that the maximum pay for any one person in one year, for any labor category, and any level of effort is $228,000. 

Yes, you may structure your budget to include all necessary components needed for success of your program.  

A cost template will be provided for those selected to submit a full proposal via SAM.gov, as discussed above. The provided cost template is expected to be filled out completely. Under no circumstances may an alternative cost template be used. 

ARPA-H will prioritize awards in accordance with Public Law No. 117-328 (Section 499A(n) of the Public Health Service Act). Without limiting the foregoing, ARPA-H will prioritize awards to domestic entities (organization and/or individuals) that will conduct funded work in the U.S. However, non-U.S. entities may participate to the extent such participants comply with nondisclosure agreements, security regulations, export control laws, and other governing statutes and regulations applicable under the circumstances. Non-U.S. entities are encouraged to collaborate with domestic U.S. entities. In no case will awards be made to entities organized under the laws of a covered foreign country (as defined in section 119C of the National Security Act of 1947 (50 U.S.C. § 3059)) or entities suspended or debarred from business with the government. 

Foreign entities are subject to a clearance review prior to beginning work on an award, whether as a prime or sub. Where the foreign entity is a sub, awards may still be made with the foreign support restricted until the clearance process is completed.