TECHNOLOGY AREA(S): Battlespace, Human Systems

ACQUISITION PROGRAM: PdM ICE Hearing Conservation Program Infantry Weapon Systems PPE

OBJECTIVE: This SBIR topic seeks to mature the technology for a low cost, passive ear protection device to be worn as an earplug and/or in a headset that will allow the warfighter to maintain situational awareness but filter out harmful noise threats with a Noise Reduction Rating (NRR) performance of greater than 30dB for both impulse and continuous noise.

DESCRIPTION: Military personnel are frequently exposed to high intensity noise resulting from blast explosions and urban warfare, and during routine military operations such as on ship decks, helicopters and armored vehicle transports. Noise levels produced by modern aircraft engines exceed 150 dB; UH-60 Blackhawk generates 85 to 120 dB. Impulse pressure from the M16 Rifle ranges between 140-190 dB. Noise level in the Marine Corps� Expeditionary Fighting Vehicle (EFV) reaches 110 dB forcing the crew to wear double hearing protection that comprises both plugs inside the ears and coverings over the ears. This high intensity noise exposure can lead to damage or loss in hearing if protective measures are not employed in advance. A recent report estimates that only about 7% of Marines insert earplugs correctly. It is not surprising that Blast and Noise-Induced Hearing Loss (B/NIHL) and tinnitus are the top two disability claims for US soldiers and veterans [GAO Report, GAO-11-114].

According to Air Force Staff Sgt. Lee Adams, an ear, nose and throat (ENT) technician at Bagram Air Field, more than 50 percent of the patients seen in the ENT walk-in clinics are there for hearing-related issues [Hood, 2009].

Furthermore, many troops do not use hearing protection while out on missions because they feel that the hearing protection negatively affects their ability to do their job and complete their missions. When service members are exposed to loud noises such as improvised explosive devices (IEDs), they are at risk of conductive hearing loss and tinnitus. Hearing protection is just as important to a U.S. military service member's safety as their body armor and helmet. A soldier who suffers severe hearing loss could find his career ending as quickly as if he had suffered other combat-related injuries [Hood, 2009].

Conventional passive hearing protection technology has evolved and matured for over half a century since it was introduced at the end of World War II. Currently, the most commonly used military passive Hearing Protection Devices (HPDs), the foam ear plugs, are inexpensive and provide good protection against acoustic noise but degrade operational capabilities to the point of danger on the practice range and the battlefield. In many circumstances the foam ear plugs are not worn properly and a dramatic loss of performance is observed with poor insertion of the earplug.

Custom molded earplugs, with deep insert provide much better protection only if the plugs are inserted completely (past the second bend of the ear canal). Deep insertion significantly improves attenuation. Active hearing protection, also known as active noise reduction (ANR), has been the subject of much research and many claims. These devices incorporate noise-canceling circuitry into hearing protectors to sense the sounds that pass through the earmuff, invert them in phase, and rebroadcast them toward the tympanic membrane via an earphone to provide active noise reduction. One of the best ANR devices was developed at the Air Force Research Laboratory (AFRL), Wright-Patterson Air Force Base. The ANR is not always beneficial if one needs to provide the maximum attenuation possible. The data [Berger 2002] comparing the attenuation for a well-fitted foam earplug, conventional earmuff, and an ANR earmuff shows that the passive dual protection substantially outperforms the ANR earmuff at nearly all frequencies. However, in situations where active radio communication is required, such as in aviation and certain military environments, ANR does provide valuable performance benefits. But, one must consider that an ANR earmuff generally costs more than $300 per pair, versus about $15 for a conventional earmuff, and a few dollars for a pair of foam ear plugs. ANR also requires regular battery replacement or recharging, which is more susceptible to damage, and will weigh more than a conventional earmuff.

This topic seeks to mature the technology for a low cost, passive ear protection device to be worn as an earplug, custom ear mold and/or in a headset that will allow the warfighter to maintain situational awareness but filter out harmful noise threats with NRR performance of greater than 30 dB for both impulse and continuous noise.

This topic seeks further development of a passive earplug and custom molded earpiece that protects the hearing of Marines in a variety of loud noise environments, while permitting spoken communications to be heard. Although the underlying technology initially will be deployed in re-useable, �universal fit� ear plugs, subsequent iterations can include placing the technology in custom-molded earplugs (with or without communications capacity) and disposable ear plugs. The base technology should not contain any moving mechanical parts or electronics eliminating the need for Marines to have access to a power source for hearing protection. Effort is to include appropriate independent lab testing and samples for field user trials.

A summary of performance attributes are:
�
� Attenuate by >30 dB the following impact noise levels while providing situational awareness: 125 dB, 140 dB, 160 dB, and 171 dB� (Required) and 190 dB (Desired)
� Provide adequate fit across the majority of the population (5th percentile � 95th percentile)
� Perform in a military operational environment without any user intervention
� Provide hearing protection with low level pass through of NRR >12
� Provide compatibility with current combat helmets and headphones
� Operate without electronic components
� Be insertable into a custom molded ear piece (if custom molding technology is used)
� Cost less than $15

PHASE I: It is expected that the proposing small business will have completed work leading up to the Phase II effort to demonstrate the achievability of the above attributes to include:
- Determined technical feasibility of the concept to address the requirements listed above in the Description section of having an approach that provided protection for high level continuous and impulse noise while still allowing detection and localization of low level sound)(80 dB and below).
- Defined and developed a concept with appropriate analysis and modeling to demonstrate performance across the audible frequency spectrum and noise levels up to 171 dB (T) 190 dB (O).
- Identified, designed, and constructed a concept model and validated the performance of the concept model ideally through independent testing of attenuation of impulse and continuous sound at amplitude above 90 dB.
- Determined technical feasibility to construct the proposed system and operational performance in the full combat environment (e.g. temperature, humidity and atmospheric pressure as defined in MIL-STD 810).
- Defined and developed a concept through the point of a model or limited prototype.
- Identified, designed, constructed and tested a concept model.
- Performed a final production cost analysis

FEASIBILITY DOCUMENTATION: Offerors interested in participating in Direct to Phase II must include in their response to this topic Phase I feasibility documentation that substantiates the scientific and technical merit and Phase I feasibility described in Phase I above has been met (i.e. the small business must have performed Phase I-type research and development related to the topic, but from non-SBIR funding sources) and describe the potential commercialization applications. The documentation provided must validate that the proposer has completed development of technology as stated in Phase I above. Documentation should include all relevant information including, but not limited to: technical reports, test data, prototype designs/models, and performance goals/results. Work submitted within the feasibility documentation must have been substantially performed by the offeror and/or the principal investigator (PI).

Read and follow all of the DON SBIR 16.3 Direct to Phase II solicitation Instructions. Phase I Proposals will NOT be accepted for this solicitation.

PHASE II: The small business will perform Phase II efforts in accordance with the Phase II contract and the Phase II statement of work. Initial tasks include the production of prototype hardware based on approved designs. Continue design modification and optimization based on performance and Marine feedback.�� Produce final hardware, complete acoustic characterization testing and finalize hardware design for certification and qualification for deployment to the extent of available funding. Deliver a minimum of 25 small, 200 medium, and 25 large ear plugs for further testing and qualification purposes.

Phase II Option, if awarded: Perform small run of Next Generation Hearing Protection Earplugs. Provide a minimum of 1,500 production sample-pairs of protective devices (150 small, 1,200 medium, 150 large) utilizing the developed production methods for field user trials. Complete Acoustic Characterization of Next Generation Hearing Protection Earplugs Perform a final refinement of the design based on the results of the field trials and lab testing.

Non-hardware deliverables include a copy of the final hardware design, a final Report containing all test results and a Marketing Plan.

PHASE III DUAL USE APPLICATIONS: Support the continued modification and qualification of improved devices as necessary.� Perform materials manufacturing development for production and scale-up. Refine the process for manufacturing the products to insure consistency and alignment with performance requirements and price points. The expected outcome is a product with a manufacturability maturity level of MRL7 or better to include preliminary production samples and a commercial production plan with detailed cost information for end items.� Develop Data package for DLA cataloging.� Private Sector Commercial Potential: In addition to aiding our Marines and other Warfighters, the technology has significant application in a variety of commercial settings. For example, workers in heavy industry are exposed to damaging impact noise. If the workers wear conventional hearing protection they are deprived of the ability to hear normal sounds such as the back-up warning on a forklift. Law enforcement officers and other first responders who often work in loud environments will benefit from the protection afforded by hearing protection technology while being able to hear their colleagues. Finally, there are a variety of consumer uses for Hearing protection, ranging from the homeowner operating a gas-powered leaf-blower to the do-it-yourself enthusiast who uses power tools. The USMC identifies four markets: (1) the military; (2) law enforcement and first responders; (3) industry; and (4) consumers. USMC market research estimates that the industrial hearing protection market alone exceeds $300 million in the United States and $800 million globally.

REFERENCES:

1. Department of Veterans Affairs. Hearing Impairment, Independent Study Course, March 2002. http://www.publichealth.va.gov/docs/vhi/hearing_impairment.pdf

2. Henderson, D., & Hamernik, R. (1995). Biologic Bases of Noise-induced Hearing Loss. Occupational Medicine: State of the Art Reviews, 10(3), 513-34.

3. C.J. Moore, An Introduction to the Psychology of Hearing, 4th ed., London: Academic Press, 1997.

4. Berger, E. (2002). Hearing Protector Performance: How They Work and What Goes Wrong in the Real World. EARLog.

5. McLeary 2008. [GAO Report, GAO-11-114].

6. Hood, O. SPC., 5th Mobile Public Affairs Detachment, �Hearing Loss No. 1 Diagnosis for U.S. Soldiers in Afghanistan�. Hearing Health Magazine, December 29, 2009.

7. ANSI S12.42-2008 Methods for the Measurement of Insertion Loss of Hearing Protection Devices in Continuous or Impulsive Noise Using Microphone-in-Real-Ear or Acoustic Test Fixture Procedures.

KEYWORDS: Hearing, Noise, Steady-State, Impulse, Non-Linear, Passive, Communication capability, Protection, Hearing protection, blast injury, tinnitus

** TOPIC AUTHOR (TPOC) **

DoD Notice:   Between August 26, 2016 and September 25, 2016 you may talk directly with the Topic Authors (TPOC) to ask technical questions about the topics. Their contact information is listed above. For reasons of competitive fairness, direct communication between proposers and topic authors is not allowed starting September 26, 2016 , when DoD begins accepting proposals for this BAA.

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