SOO - Phase III SBIR - Multi-Function Ear Probe Integration and Study Support - 05252022.docx

Statement of Objectives (SOO) for Multi-Function Ear Probe Integration and Study Support

National Military Audiology and Speech Pathology Center (NMASC), within the Walter Reed National Military Medical Center (WRNMMC), in conjunction with the Army Public Health Center (APHC) and the DoD Hearing Center of Excellence (HCE)

1.0. Introduction

For the primary task, the contractor shall make modifications and improvements to the M-Plug and the Integrated Platform for Clinical Assessment and Monitoring (IPCAM) infrastructure to allow the NMASC, HCE, and the APHC to execute research studies and public health projects that utilize IPCAM to evaluate the effects of noise exposure on human listeners. The current IPCAM infrastructure includes the WAHTS boothless audiometer, Hear Track, the mNOISE dosimeter and the TabSINT software package for administering hearing studies. A particular emphasis will be placed on adapting the TabSINT architecture to incorporate Creare’s M-Plug developed under a previous Phase II SBIR contract W81XWH-19-C-0076 titled “Multi-Function In-Ear Probe” into the IPCAM infrastructure. In the second task, the contractor shall provide or procure technical support to the NMASC, HCE, and APHC for the execution of studies that use the M-Plug and IPCAM infrastructure to evaluate the effects of acute and chronic noise exposure on human listeners.

1.1. Mission

The mission of the Scientific and Clinical Studies Section (SCSS) within the NMASC is to conduct basic, applied and translational research to support the audiology and speech pathology programs of WRNMMC as well as the Department of Defense and related government entities. Our goal is to conduct research to improve the prevention, diagnosis, treatment and rehabilitation of auditory, vestibular, speech, voice, language, and swallowing impairments and other communication disorders.

The mission of the HCE is to optimize operational effectiveness, heighten medical readiness, and enhance quality of life through collaborative leadership and advocacy for hearing and balance health initiatives.

The APHC’s mission is to promote health and prevent disease, injury, and disability of Soldiers and military retirees, their Families, and Department of the Army civilian employees; and assure effective execution of full spectrum veterinary service for Army and Department of Defense Veterinary missions. The mission of the Hearing Conservation and Readiness Branch is to enhance hearing readiness and conservation by identifying and assessing current and emerging hearing threats, developing and communicating hearing health solutions, and assuring the quality and effectiveness of the Army's Hearing Program.

The efforts described herein support the mission of the SCSS, in partnership with the HCE and APHC, to develop new evidence based methods for determining hearing readiness, to evaluate the effectiveness of hearing conservation strategies both in the field and the clinic, and to provide advanced clinical tools for assessing and treating hearing loss and tinnitus.

1.2. Background

Noise exposure is a serious problem in the military and is reflected in the high prevalence of hearing loss and tinnitus sustained by our service members. Often, the design of a weapon system that maximizes lethality and mission success must be balanced against warfighter safety, survivability, and health hazards (Amrein & Letowski, 2011). If not properly accounted for, noise hazards may jeopardize a soldier’s ability to be deployed or continue in communication-critical job duties. In order to address this problem, much work has been done to develop military standards that provide design criteria on test and measurement techniques that accurately measure noise levels outlined in MIL-STD-1474E (Department of Defense, 2015) and establish damage risk criteria (DRC) that will minimize hearing damage caused by acoustic energy and blast overpressure produced by military weapon systems. This replies primarily on (1) the acoustic measurement of complex noise environments and (2) subsequent hearing assessment to evaluate temporary threshold shifts (TTS) due to noise exposure.

In regards to measurement of noise, there is currently no consensus among experts in the occupational, military, and scientific communities as to the extent of the hazard to hearing from exposure to impulsive sounds. Until recently, the underlying assumption for DRC was that hearing loss was related to the total energy exposure (a time-intensity relationship) but was independent of the temporal distribution of this exposure. However, several studies have demonstrated that this is not always the case (Henderson, et al. 2012; Qiu et al., 2020). In addition, high-intensity impulse sounds are generally considered to be more damaging than continuous sounds (Le, et al. 2017), yet there is no commercial noise dosimetry system available for surveying impulsive noise environments or for qualifying weapons systems that produce impulse noise. Engineers, scientists, and industrial hygienists involved in measuring human exposure to impulsive noise continue to rely on nonstandard, and laboratory grade equipment to collect exposure data. Field studies are especially challenging due to the size, portability, and performance limitations of such equipment (Smalt, et al. 2017).

Limitations are also present in traditional methods for measuring changes in auditory performance. Except in the most extreme cases, TTS as a result of blast or impulse noise exposure resolves very quickly. In fact, the rates of recovery associated with noise exposure are found to be directly dependent on the amounts of TTS, with larger post-impulse noise TTS resolving more quickly than smaller post-impulse noise TTS (Chan et al., 2016). In order to accurately capture the magnitude of hearing change associated with the noise and blast exposure found in the military training environment, there needs to be a focus on evaluating participants as close in time to blast-incidence as possible. This makes standard methods of testing hearing acuity difficult, as it typically requires study participants to leave the austere training environments where hazardous noise exposure is incurred and travel to a nearby facility with sound-isolating booths and audiometric test equipment. This ultimately limits the extent to which auditory changes are able to be identified.

At the same time, there is mounting evidence that even relatively brief TTS exposures may lead to significant hearing problems. Survey data collected on over 3,000 service members from WRNMMC hearing conservation clinics indicated that even infrequent TTS that lasts for a relatively brief time (minutes) appear to be associated with higher rates of hearing difficulties. Thus, we believe the ability to assess small changes of hearing in the time period immediately following exposure to a weapon system or blast event is of paramount importance to our goal of establishing accurate hearing risk criteria that protect the warfighter while not unnecessarily limiting the capabilities of the weapon system.

To address these concerns, the NMASC at WRNMMC, in conjunction with the HCE and APHC, have been conducting a program of research to establish a direct link between noise/blast exposure and auditory function, as well as a direct link between auditory acuity and quantitative measures of operational effectiveness in military tasks. The long-term aim of this research is to develop effective strategies for hearing conservation and realistic hearing tests that provide useful information to decision-making authorities regarding listening and communication capabilities of service members in various military environments. A substantial component of this effort is being conducted through the use of a distributed network of tablet-based audio test systems that have been developed, refined, and expanded to incorporate new features/technologies under a series of previous SBIR contracts (e.g. W81XWH-13-C-0194, W81XWH-16-C-0015, W81XWH-20-C-0070). This IPCAM infrastructure is based on an open-source platform known as TabSINT and utilizes wireless noise attenuating audiometric headsets known as the Wireless Automated Hearing Test Sytem (WAHTS), which allows data collection for survey and listening tests at distributed sites, new clinical and research protocols to be distributed via cloud, take-home applications for implementing aural rehabilitation strategies, continuous monitoring of background monitoring of background noise at the site of test administration, measurement of both impulse and continuous noise exposure via the mNOISE, and optical scanning techniques for transferring data to the medical record. Many of the personnel, other direct costs, and travel required to execute the studies that utilize this IPCAM infrastructure are currently being provided via a 5-year IDIQ contract through USAHCA (W81K04-21-D-0017).

In parallel to the IPCAM development effort, Creare recently completed a Phase II SBIR contract titled “Multi-Function Ear Probe” in which they developed a prototype multi-function in-ear probe (M-Plug) that is integrated into a hearing protector to monitor noise exposure and assess changes in hearing function with minimal impact on standard military operating procedures. This in-ear system will (1) provide hearing protection during activities in noisy environments; (2) record personal noise dose based on sound levels measured in the environment versus underneath the plug; and (3) monitor hearing function over time. This will allow users to continuously monitor the noise environment while evaluating the potential impact of auditory insults as close in time to the injury as possible. This will allow the NMASC and its partner organizations to overcome many of the limitations outlined in the introductory paragraphs above.

Thus, the primary objective of this Phase III SBIR contract effort is to provide support for maintaining and expanding the IPCAM infrastructure to incorporate this new M-Plug technology. In addition, there are many planned/ongoing studies that utilize IPCAM to evaluate the effects of noise exposure on human listeners that could greatly benefit from incorporating the M-Plug. Thus, the SOO also outlines the provision of technical and logistical support to these studies.

1.3. Scope

This contract provides support for two Phase III Tasks. In Task 1, the contractor shall make modifications and improvements to the M-Plug and IPCAM infrastructure to allow the NMASC, HCE, and the APHC to execute research studies and public health projects that utilize IPCAM to evaluate the effects of noise exposure on human listeners. In Task 2, the contractor shall provide or procure technical support to the NMASC, HCE, and APHC for the execution of studies that use the M-Plug and the IPCAM infrastructure to evaluate the effects of acute and chronic noise exposure on human listeners.

2.0 Specific Tasks

2.1 Task 1. Develop and Refine IPCAM Infrastructure to Incorporate the M-Plug into Studies Evaluating the Effects of Noise Exposure on Human Listeners The goal of this task will be to make modifications and improvements to the M-Plug and IPCAM infrastructure to allow the NMASC, HCE, and the APHC to execute research studies and public health projects that utilize IPCAM to evaluate the effects of noise exposure on human listeners. The IPCAM infrastructure includes the M-Plug in-ear monitoring system, as well as the mNOISE dosimetry system, the WAHTS boothless audiometer system, Hear Track, and the TabSINT software package for administering hearing studies.

· Modification, verification, and pilot testing of the TabSINT and/or Hear Track software base to address bugs, implement new feature requests, and make changes required to perform new hearing tests implemented in firmware.

· Development and pilot testing of tools that allow TabSINT protocols to control the M-Plug automatically or from a distance and allow M-Plug results to be viewed remotely.

· Modification to the IPCAM firmware to address bugs and make changes required to perform new types of hearing tests or to modify existing tests in response to emerging applications (e.g., remote hearing testing to maintain hearing conservation programs without requiring service members to come to a hospital/clinic or to triage patients during deployed operations).

· Testing of all changes made to TabSINT, WAHTS, M-Plug or Hear Track. As the software has reached a certain level of maturity, and is used across a wide variety of test sites, testing becomes increasingly important before any release of new features to ensure any new functionality does not adversely affect the rest of the software.

· Developing data analysis tools to allow researchers to view subject data quickly and efficiently.

2.2 Provide Technical and Logistical Support for Noise Exposure Studies that use the M-Plug/IPCAM

The goal of this task will be to provide or procure technical support to the NMASC, HCE, and APHC for the execution of studies that use the M-Plug and the IPCAM infrastructure to evaluate the effects of acute and chronic noise exposure on human listeners.

· The procurement, integration, reconfiguration (if necessary), transportation, installation, documentation, calibration, and support of hardware and software systems that allow the NMASC, HCE, or APHC to use the IPCAM infrastructure to conduct studies evaluating the effects of noise exposure on human listeners.

· Consultation and support for the analysis of data collected in studies using the IPCAM infrastructure.

· Maintaining access to the TabSINT server system for distributing protocols and maintaining a database of de-identified study data.

· Documentation of all changes and updates to TabSINT on tabsint.org.

· Hardware maintenance and support to include maintenance and calibration of WAHTS, M-Plugs, and mNOISE owned by the NMASC, HCE, and APHC.

3.0 Other Direct Costs (ODCs)

In addition to any subcontractors and/or consultants, we anticipate some travel and equipment costs to be incurred.

3.1 Travel

Approximately 3 trips to attend kickoff/review meetings, field data collection support, conferences, trainings, and/or demonstrations at the Government’s direction/request.

3.2 Equipment

Purchased parts such as tablets, headphones, smartphones will be required. In addition, Amazon Web Services cloud server services may be required to maintain the server.

4.0 Period of Performance

The anticipated period of performance is for one year from 26 Sep 2022 to 25 Sep 2023.