3D Laser Ear Measurement for Custom Hearing Products – tackling the MOST PREVALENT military service-connected disability

SPONSOR: Valerie S. Bjorn Physiologist Naval Air Systems Command (AIR co-located at Arnold Engineering Development Ctr. AEDC TSTW 740 Fourth St. Arnold AFB, TN 37389-6000 (931) 454-6046, DSN 340 valerie.bjorn@arnold.af.mil

Problem and Solution

According the Department of Veterans Affairs, the MOST PREVALENT service-connected disabilities for veterans receiving federal compensation in 2011 were tinnitus (ringing in the ear) and hearing loss, respectively – over 1.5 million with annual payments for such conditions exceeding $1.1 billion!

The GAO Report to Congressional Committees in January 2011 stated, ”Although DOD requires that noise be controlled by setting exposure limits and requiring the use of hearing protection, these strategies are not consistently used. For example, service members told us that they do not always wear hearing protection, citing concerns with comfort and communication. Annual hearing-related training is required for at-risk service members, but services are not able to fully determine who has completed annual training, and many service members told the GAO that training is not necessarily well timed.”

Informing service personnel of potential hearing loss and providing them training on proper hearing protection is not enough. Why? One reason is standard one-size-fits-all earplugs do not really fit everyone and do not insert correctly each time worn. Users cannot see their own ears to tell if earplug insertion depth is adequate. Further, the prolonged uncomfortable expansion force of many universal fit earplugs can become uncomfortable and also cause earplugs to work themselves loose.

The solution is for service personnel to want to wear their hearing protection and for it to fit correctly to ensure highest attenuation levels are achieved and maintained. This led some in the DOD to pursue custom earplugs for war fighters and to invest in developing a capability to capture ear canal shape data quickly, safely, and accurately. This has been an elusive goal – until now!

Started as a US Navy SBIR project, 3DM Systems developed the Otoscan Laser Ear Scanner to capture the exact dimensions of the outer ear and inner ear canal. The resulting data file is used to produce custom hearing protection devices. The scanner resembles an otoscope that is inserted inside the ear; however, an audiologist or specialist in NOT required. The 3D laser projection and capture technology replaces the need for costly and potentially harmful silicone impressions that have an unacceptable error rate.

Innovativeness and Implementation Ease

The Otoscan is the only noninvasive in-the-ear 3D optical-laser scanner for direct, digital capture of the outer ear and the ear canal all the way to the eardrum. The Otoscan also functions and resembles standard otoscopes commonly used to look in ears. The added benefit of the Otoscan also includes the only video otoscope with high definition and super-wide-angle functionality. Simply stated, the Otoscan can be used as a one-for-one replacement for an otoscope but also to capture complete ear canal shape data for the design and manufacture of all in-ear products.

The 3DM Systems Otoscan was named "Best New Product" in the Audiology Solutions New Product Showcase by attendees at the 2012 AudiologyNOW! Conference of the American Academy of Audiology. GN Store Nord, a Danish-owned global company that manufactures and sells products such as Jabra brand headsets and ReSound, Beltone and Interton brand hearing instruments, recently entered into a license agreement with 3DM Systems to manufacture and distribute the Otoscan device for the global hearing aid market .

Technology Target Scalability – Military Active Duty, Veteran, and Non-military

The target for this technology is US Navy, Marine, Army, and Air Force war fighters who are routinely exposed to high noise, often for long daily exposures, be it aircraft, vehicle, equipment, or impulse noise from weapons and explosives. Beyond active duty personnel, the 3DM Systems ear scanner can be used to ensure a proper fit for the hundreds of thousands of veterans and non-military who require hearing aids and custom ear products. Improper fit and comfort are major reasons why users have not been satisfied with their custom in-ear products and in many cases refuse to wear them. The 3DM Systems scanner affords a huge cost-time-cumber reduction over the legacy silicone impression method which often requires earmold remakes.

Cost Effectiveness

The 3DM Systems Otoscan Laser Ear Scanner is more accurate, efficient, safe, and cost effective than legacy earmold impressions (see attached table).

Proposed Study and Funding Requirements

3DM Systems recently completed their US Navy SBIR Phase II effort. Their Otoscan Laser Ear Scanner and is at Technology Readiness Level (TRL) "6/7" – prototype demonstrated in a relevant environment. The proposed study would facilitate transition to TRL 9 – the actual system proven successful in operational environments.

In the proposed pilot study, the actual system (ready for market) will be used in a human usability project led by the Naval Air System Command. The project will validate ear scan precision, fit, comfort, and data suitability for making custom earplugs. 3DM Systems ear scanner comparisons will be made against legacy silicone earmold impressions. Study participants will initially include active duty personnel. A follow-on effort would be proposed for veterans targeted to wear in-the-ear hearing aids.

The pilot study is targeted to begin in Q3 2013 and will be completed no later than January 2014. The funding required is $50,000 to support the cost for 3DM Systems to provide one person to collect and manage 360 3D laser scans on study participants at up to 6 US Navy and Marine bases. Funding will support related labor, travel, and material (scanner repairs, replacements, modification) expenses. 3D laser vendor participation in the study will be managed under the supervision of a Naval Air Systems Command scientist or other designated military/government person leading access to the various bases and personnel (funding for these individuals is from other sources).

Judging Criteria

Innovativeness - How innovative is the idea?

Answer: Never before has the ability existed to obtain an ultra-precise measurement of the outer and inner ear canal. This capability is now possible through the use of a 3D laser scanner.

The legacy silicone impression method can have up to an 18% re-make rate due to an imprecise measurement process (silicone can stretch the ear and may not completely fill the ear canal). An imprecise measurement results in a bad fit (uncomfortable so frequently removed and the level of sound protection is reduced – both place service personnel at risk for hearing loss). In addition, the person receiving a silicone impression is placed in harm’s way should the silicone impression go past the protective dam and hit the tympanic membrane.

Cost Effectiveness - How cost effective is the idea? Will it yield a return on investment?

Answer: Legacy per ear silicone impression cost is between $50 and $100. The new 3D laser scanner will be priced between $10 and $25 per scan. The cost savings in terms of quality of life is immeasurable. Disability payments for veterans receiving federal compensation in 2011 for tinnitus (ringing in the ear) and hearing loss exceeded $1.1 billion. The use of the 3D laser scanner for active duty personnel should substantially reduce future disability payments.

Ease of Implementation - How complex will the implementation be? Will several policy/law exceptions need to be made? Will buy-in from the organization be required before implementation?

Answer: The 3D laser scanners can be placed at select military base locations and scanning performed by trained military personnel (an Audiologist is NOT required). Buy-in from the organization may not be required dependent upon the Implementation Agreement developed with 3D laser vendor.

Scalability - If the idea is proven to be successful, will it be scalable to the entire Military Health System?

Answer: Absolutely

Tri-Service - Is the idea Tri-Service, or is it Service specific? If it is Service specific can it be modified to support all Services?

Answer: The innovation is Tri-Service.

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