Opportunity Information: Apply for PA 06 546

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "New Technology to Screen for Mild Hearing Loss in Children (SBIR R43/R44)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.173 Research Related to Deafness and Communication Disorders 93.283 Centers for Disease Control and PreventionInvestigations and Technical Assistance.
  • This funding opportunity was created on Jan 26, 2009 and posted on Sep 8, 2006.
  • Applicants must submit their applications by Sep 7, 2009 Multiple Receipt Dates See Link to Full Announcement for details.. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Eligible applicants include: Small businesses Others (see text field entitled Additional Information on Eligibility for clarification).
  • Foreign institutions are not eligible to apply. The NIH will accept as many different applications as the applicant organization chooses. However, the NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process or service that, with non substantive modifications, can be applied to a variety of purposes. Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and another HHS FOA, including the current SBIR or STTR Parent FOAs.
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Opportunity Summary:

The grant opportunity titled "New Technology to Screen for Mild Hearing Loss in Children (SBIR R43/R44)" invites proposals from small business concerns to create, improve, or adapt screening tools that can more reliably pick up mild hearing loss in infants and young children. The central problem the announcement targets is that many current screening approaches do a good job identifying moderate to profound hearing loss, but can miss milder losses, especially those under 40 dB Hearing Level (40 dB HL), in one ear or both. The goal is to push development of technology that raises sensitivity for these mild cases without also driving up the rate of false positives, meaning children who fail the screening even though they do not actually have hearing loss. In practical terms, the government is looking for innovations that catch more true cases of mild hearing loss while keeping screening programs efficient and trustworthy for families and healthcare systems.

The public health motivation behind the FOA is tied to early identification and timely intervention. The Early Hearing Detection and Intervention (EHDI) program, housed within the National Center for Birth Defects and Developmental Disabilities (NCBDDD) at the Centers for Disease Control and Prevention (CDC), along with the National Institute on Deafness and Other Communication Disorders (NIDCD) at the National Institutes of Health (NIH), emphasize that earlier detection can meaningfully improve a child s access to language input, communication development, and support services. Mild hearing loss can be harder to notice clinically and can still affect speech and language outcomes, classroom performance, and social development, so the agencies are encouraging technology that makes detection more consistent and dependable at very young ages.

This FOA uses the Small Business Innovation Research (SBIR) mechanisms, specifically R43 and R44, which cover Phase I, Phase II, and Fast Track submissions. Phase I generally supports early feasibility and proof of concept work, Phase II supports more advanced development and testing, and the Fast Track route is designed to move more seamlessly from Phase I into Phase II with an integrated application. The scientific scope is mirrored by a parallel announcement (PA 06 547) that uses the Small Business Technology Transfer (STTR) mechanisms (R41/R42), but an important administrative detail is that CDC does not accept STTR applications. Because of that, CDC s participation is limited to this SBIR announcement (PA 06 546), even though the overall topic and goals align across the SBIR and STTR versions.

In terms of what applicants are expected to propose, the emphasis is on screening technologies suited for infants and young children, and specifically on improving performance for mild losses below 40 dB HL. The announcement is not limited to one particular device type or method in the text provided, but it is clearly aimed at practical screening solutions that can be deployed in real world early childhood settings. The key performance requirement is a better balance of sensitivity and specificity for mild hearing loss: detect more true mild cases while avoiding unnecessary referrals and follow up testing caused by false positives. This is important because screening programs operate at scale, and even small increases in false positive rates can translate into a large number of families experiencing stress, extra appointments, and added healthcare costs.

Administratively, the opportunity is identified as PA 06 546 and categorized as discretionary grant funding in the health area. It lists CFDA numbers 93.173 (Research Related to Deafness and Communication Disorders) and 93.283 (CDC Investigations and Technical Assistance), reflecting the involvement of NIH and CDC interests. There is no cost sharing or matching requirement stated, which typically makes participation easier for small businesses because it does not require them to contribute a defined portion of project costs as a condition of the award.

Eligibility is centered on small businesses, with additional eligibility details referenced in the full announcement. Foreign institutions are explicitly not eligible to apply. The NIH policy notes that an applicant organization may submit multiple different applications, but NIH will not accept essentially the same project more than once from the same organization, including derivative submissions that are basically the same product with only non substantive modifications for different uses. Applicants also cannot submit identical or essentially identical applications under this FOA and another HHS funding opportunity announcement at the same time, including the SBIR or STTR Parent FOAs, which is meant to prevent duplicate review of the same proposal across multiple solicitations.

The posting history included in the record shows it was posted September 8, 2006, with multiple receipt dates and a closing window that ultimately listed September 7, 2009 as the current closing date, and an archive date of October 7, 2009. The announcement indicates applicants should consult the full FOA for the specific receipt dates and submission details, since these SBIR announcements often operate with recurring deadlines during the active period rather than a single one time due date. For access or technical issues related to the online announcement, the listed point of contact is the NIH Office of Extramural Research (OER) webmaster email.

Overall, the opportunity is best understood as a targeted SBIR call for small businesses to bring forward innovations that can make pediatric hearing screening more sensitive to mild hearing loss while staying accurate enough to avoid overwhelming families and healthcare systems with false alarms. It sits at the intersection of technology development and early childhood public health, with the shared aim of helping children with even subtle hearing deficits get identified and supported as early as possible.

Frequently Asked Questions

What is the name of this grant opportunity?

The opportunity is titled "New Technology to Screen for Mild Hearing Loss in Children (SBIR R43/R44)."

What problem is this funding opportunity trying to solve?

It targets a known gap in pediatric hearing screening: many current approaches reliably detect moderate to profound hearing loss, but can miss mild hearing loss, especially losses under 40 dB Hearing Level (40 dB HL), whether in one ear or both.

What is the main goal of projects supported under this FOA?

The goal is to create, improve, or adapt screening tools that detect more true cases of mild hearing loss in infants and young children while avoiding an increase in false positives (children who fail screening even though they do not actually have hearing loss).

What population should the proposed screening technology be suited for?

The emphasis is on screening technologies suited for infants and young children and deployable in real-world early childhood settings.

What level of hearing loss is specifically emphasized?

The FOA emphasizes improved screening performance for mild hearing losses below 40 dB HL.

What does the FOA mean by improving the balance of sensitivity and specificity?

It means increasing sensitivity so the screening identifies more true mild hearing loss cases, while maintaining specificity so the program does not generate unnecessary referrals due to false positives.

Why is minimizing false positives important in this program?

Screening programs operate at scale, and even small increases in false positives can lead to many families experiencing stress and additional appointments, and can increase healthcare system costs and burden follow-up services.

What funding mechanism is used for this opportunity?

This FOA uses the Small Business Innovation Research (SBIR) mechanisms R43 and R44, supporting Phase I, Phase II, and Fast Track submissions.

What is supported in SBIR Phase I versus Phase II?

Phase I generally supports early feasibility and proof-of-concept work. Phase II supports more advanced development and testing.

What is the SBIR Fast Track option mentioned in the announcement?

Fast Track is designed to move more seamlessly from Phase I into Phase II through an integrated application that covers both phases.

Is this opportunity connected to an STTR announcement as well?

Yes. The scientific scope is mirrored by a parallel announcement that uses the Small Business Technology Transfer (STTR) mechanisms (R41/R42), identified as PA 06 547.

Does CDC accept STTR applications for this topic?

No. The information provided states that CDC does not accept STTR applications, and therefore CDC participation is limited to this SBIR announcement (PA 06 546).

What is the FOA number for this SBIR opportunity?

The opportunity is identified as PA 06 546.

Which agencies and programs are tied to the public health motivation for this topic?

The public health motivation is linked to the Early Hearing Detection and Intervention (EHDI) program within the National Center for Birth Defects and Developmental Disabilities (NCBDDD) at CDC, and to the National Institute on Deafness and Other Communication Disorders (NIDCD) at NIH.

Why does the government emphasize early identification of hearing loss?

Earlier detection and timely intervention can improve a child's access to language input, communication development, and support services, which can influence speech and language outcomes, classroom performance, and social development.

What types of technologies are eligible to propose?

The text provided does not restrict applicants to a single device type or method. It broadly encourages practical screening solutions aimed at improving detection reliability for mild hearing loss in infants and young children.

Is this considered discretionary grant funding?

Yes. The opportunity is categorized as discretionary grant funding in the health area.

What CFDA numbers are associated with this opportunity?

The listing includes CFDA 93.173 (Research Related to Deafness and Communication Disorders) and CFDA 93.283 (CDC Investigations and Technical Assistance).

Is there a cost-sharing or matching requirement?

No cost sharing or matching requirement is stated in the information provided.

Who is eligible to apply?

Eligibility is centered on small business concerns, with additional eligibility details referenced in the full announcement.

Are foreign institutions eligible to apply?

No. Foreign institutions are explicitly not eligible to apply.

Can an organization submit more than one application?

Yes. The NIH policy referenced indicates an applicant organization may submit multiple different applications.

Are there restrictions on submitting similar or duplicate projects?

Yes. NIH will not accept essentially the same project more than once from the same organization, including derivative submissions that are basically the same product with only non-substantive modifications for different uses.

Can applicants submit the same proposal to this FOA and another HHS opportunity at the same time?

No. Applicants cannot submit identical or essentially identical applications under this FOA and another HHS funding opportunity announcement at the same time, including the SBIR or STTR Parent FOAs.

When was this opportunity posted, and what are the closing and archive dates shown in the record?

The record shows the opportunity was posted on September 8, 2006. It lists September 7, 2009 as the current closing date and an archive date of October 7, 2009.

Does this FOA have one deadline or recurring receipt dates?

The record indicates multiple receipt dates and notes that applicants should consult the full FOA for specific receipt dates and submission details, since SBIR announcements often use recurring deadlines during the active period.

Where should applicants look for the exact submission and receipt-date instructions?

The announcement directs applicants to consult the full FOA for the specific receipt dates and submission details.

Who is listed as the contact for access or technical issues related to the online announcement?

The listed point of contact for access or technical issues is the NIH Office of Extramural Research (OER) webmaster email.

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