2
Evaluation of the Hearing Loss Research Program

The committee was charged with reviewing the Hearing Loss Research Program of the National Institute for Occupational Safety and Health (NIOSH) to evaluate the relevance of its work to improvements in occupational safety and health and the impact that NIOSH research has had in reducing workplace illnesses and injuries. The committee’s review focused on the work of the Hearing Loss Research Program primarily during the period 1996 through 2005. Information about some NIOSH activities during the first few months of 2006 was included in the committee’s review. The committee followed the Framework Document developed by the Committee to Review NIOSH Research Programs (see Appendix A). This review framework directs that relevance be evaluated in terms of the degree of research priority and connection to improvements in workplace protection. It identifies factors to take into account including the frequency and severity of health outcomes and the number of people at risk, the structure of the program, and the degree of consideration of stakeholder input (see Appendix A). Research impact is to be evaluated in terms of its contributions to worker health and safety, to the extent that this can be known or surmised. This chapter presents the results of the committee’s review, reported in the form of qualitative assessments of the relevance and impact of the Hearing Loss Research Program’s research and other activities.

Following the guidance of the Framework Document, the committee carried out its evaluation using the terminology and organization of a logic model adopted by NIOSH to characterize the steps in its work. An examination of goals, inputs,



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Hearing Loss Research at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health 2 Evaluation of the Hearing Loss Research Program The committee was charged with reviewing the Hearing Loss Research Program of the National Institute for Occupational Safety and Health (NIOSH) to evaluate the relevance of its work to improvements in occupational safety and health and the impact that NIOSH research has had in reducing workplace illnesses and injuries. The committee’s review focused on the work of the Hearing Loss Research Program primarily during the period 1996 through 2005. Information about some NIOSH activities during the first few months of 2006 was included in the committee’s review. The committee followed the Framework Document developed by the Committee to Review NIOSH Research Programs (see Appendix A). This review framework directs that relevance be evaluated in terms of the degree of research priority and connection to improvements in workplace protection. It identifies factors to take into account including the frequency and severity of health outcomes and the number of people at risk, the structure of the program, and the degree of consideration of stakeholder input (see Appendix A). Research impact is to be evaluated in terms of its contributions to worker health and safety, to the extent that this can be known or surmised. This chapter presents the results of the committee’s review, reported in the form of qualitative assessments of the relevance and impact of the Hearing Loss Research Program’s research and other activities. Following the guidance of the Framework Document, the committee carried out its evaluation using the terminology and organization of a logic model adopted by NIOSH to characterize the steps in its work. An examination of goals, inputs,

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Hearing Loss Research at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health activities, and outputs was used to assess the relevance of the program’s research. End outcomes and intermediate outcomes were examined to evaluate the impact of the program’s research. Illustrative examples of each of these terms as used in this report are provided in Box 2-1. The chapter’s sections on relevance and impact each conclude with a summary section with the committee’s overall assessment of and quantitative scores for the relevance or impact of the Hearing Loss Research Program, respectively. The committee also identified important factors beyond the program’s control that affect its activities and performance. The “external” factors with the broadest reach are discussed before the committee’s assessments of the program’s relevance and impact. External factors that have a more limited effect on the program’s work are noted at appropriate points throughout the discussions of the program’s relevance and impact. HEARING LOSS RESEARCH PROGRAM GOALS In 2005, NIOSH established four research goals for the Hearing Loss Research Program, under which programs of varying breadth are being pursued (see Table 2-1). NIOSH also used these four new research goals to organize the primary evidence package provided to the committee and its presentations to the committee. In turn, the committee decided to use the four goals to organize its detailed examination of the Hearing Loss Research Program, while recognizing that these research goals were not in use by the program during most of the period covered by the retrospective assessment. As noted in Chapter 1, the four research goals encompass eight of the nine research needs identified in 1998 (NIOSH, 1998a) that guided the program’s work between 1998 and 2005. The 1998 goals also reflect the priority areas of “hearing loss” and “mixed exposures” that were established in conjunction with the first National Occupational Research Agenda (NORA), as well as some work related to the NORA priority areas of “control technology and personal protective equipment,” “exposure assessment methods,” and “intervention effectiveness research” (NIOSH, 2005d). In the sections that follow, the presentation of the committee’s findings addresses both the overall program and matters concerning individual research goals. EXTERNAL FACTORS WITH BROAD EFFECTS ON THE HEARING LOSS RESEARCH PROGRAM The Hearing Loss Research Program operates in an environment shaped by many factors that the program cannot control. Some of these factors are so fundamental to the nature of the program that the committee found it essential to keep them in mind for all aspects of its review.

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Hearing Loss Research at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health BOX 2-1 Logic Model Terms and Examples Planning Inputs: Stakeholder input, surveillance and intervention data, and risk assessments (e.g., input from Federal Advisory Committee Act panels or the National Occupational Research Agenda research partners, intramural surveillance information, Health Hazard Evaluations [HHEs]). Production Inputs: Intramural and extramural funding, staffing, management structure, and physical facilities. Activities: Efforts and work of the program, staff, grantees, and contractors (e.g., surveillance, health effects research, intervention research, health services research, information dissemination, training, and technical assistance). Outputs: A direct product of a NIOSH research program that is logically related to the achievement of desirable and intended outcomes (e.g., publications in peer-reviewed journals, recommendations, reports, website content, workshops and presentations, databases, educational materials, scales and methods, new technologies, patents, and technical assistance). Intermediate Outcomes: Related to the program’s association with behaviors and changes at individual, group, and organizational levels in the workplace. An assessment of the worth of NIOSH research and its products by outside stakeholders (e.g., production of standards or regulations based in whole or in part on NIOSH research; attendance at training and education programs sponsored by other organizations; use of publications, technologies, methods, or recommendations by workers, industry, and occupational safety and health professionals in the field; and citations of NIOSH research by industry and academic scientists). End Outcomes: Improvements in safety and health in the workplace. Defined by measures of health and safety and of impact on processes and programs (e.g., changes related to health, including decreases in injuries, illnesses, or deaths and decreases in exposures due to research in a specific program or subprogram). External Factors: Actions or forces beyond NIOSH’s control (e.g., by industry, labor, regulators, and other entities) with important bearing on the incorporation in the workplace of NIOSH’s outputs to enhance health and safety. SOURCE: Framework Document (see Appendix A). First, there are important limits to the ability of the NIOSH Hearing Loss Research Program to effect change in the workplace. As part of a research agency, the program is in a position to produce knowledge about workplace injuries (i.e., occupational hearing loss), noise hazards, effective hearing protection devices, and hearing conservation practices. NIOSH can also work to promote the application of this knowledge in the workplace. The actual responsibility for minimizing haz-

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Hearing Loss Research at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health TABLE 2-1 Research Goals and Subgoals of the NIOSH Hearing Loss Research Program, as of February 2006 Research Goal 1: Contribute to the Development, Implementation, and Evaluation of Effective Hearing Loss Prevention Programs 1.1. Develop criteria and recommendations for preventing occupational hearing loss 1.2. Develop a practical guide for preventing occupational hearing loss 1.3. Achieve a better understanding of the combined effects of continuous and impulsive noise exposures 1.4. Develop data management tools for hearing loss prevention programs 1.5. Develop a hearing loss simulator 1.6. Develop a survey instrument to evaluate training effectiveness 1.7. Develop an evaluation checklist for hearing loss prevention programs 1.8. Develop training focused on improving hearing protection device use 1.9. Develop a core curriculum in occupational safety and health for high school and post-secondary students that includes a module on hearing loss prevention 1.10. Develop a hearing protector device compendium Research Goal 2: Reduce Hearing Loss Through Interventions Targeting Personal Protective Equipment 2.1. Develop measurement and rating methods that are representative of real-world performance of hearing protection devices 2.2. Develop hearing protection laboratory and fit-testing methods 2.3. Evaluate the effectiveness of hearing protection devices against impulsive noise 2.4. Develop a hearing protection and communication system 2.5. Develop hearing protection recommendations for noise-exposed hearing-impaired workers Resear ch Goal 3: Develop Engineering Controls to Reduce Noise Exposures 3.1. Reduce noise on continuous mining machines using coated flight bars 3.2. Reduce noise generated by roof bolting machines using wet and mist drilling 3.3. Reduce noise exposures to construction workers using a web-based database for powered hand tools Research Goal 4: Improve Understanding of Occupational Hearing Loss Through Surveillance and Investigation of Risk Factors 4.1. Determine occupational noise exposure and hearing loss through national surveillance 4.2. Characterize hearing ability in the general population through national databases 4.3. Prevent hearing loss from impulsive noise through development of standards and instrumentation 4.4. Improve detection and prevention of occupational hearing loss by understanding the aging component 4.5. Prevent hearing loss by understanding the role of genetics in susceptibility to noise 4.6. Prevent hearing loss from exposure to ototoxic chemicals alone or in combination with noise SOURCE: NIOSH, 2005f,g,h,i.

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Hearing Loss Research at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health ardous workplace noise environments and ensuring worker compliance with hearing conservation programs lies with employers, who must respond to both economic and regulatory imperatives. Some employers may resist implementation of optimum noise control measures because they are concerned, rightly or wrongly, about the possible economic impact of such measures. Authority to establish and enforce regulations concerning workplace noise exposure and hearing conservation lies with regulatory agencies such as the Occupational Safety and Health Administration (OSHA) and the Mine Safety and Health Administration (MSHA) (both of which are part of the U.S. Department of Labor). NIOSH is expected to make recommendations to these agencies, but the agencies must consider the views of other interested parties, who may have concerns that differ from those of NIOSH. Gaining and sustaining attention to occupational hearing loss may sometimes be difficult. The condition is relatively slow to emerge, rarely requires immediate medical attention or time lost from work, and is not fatal. Longitudinal studies are often needed to test the effectiveness of new approaches to elements of hearing loss prevention programs, and such studies require willing collaboration by employers and workers. Factors such as changes in management or fiscal conditions may lead companies to withdraw from research collaborations, and turnover in the workforce may compromise the stability of study populations. Another important consideration is that the Hearing Loss Research Program comprises a collection of activities taking place principally within five organizational units of NIOSH. Thus, the “program” is based on a matrix approach, not on being an identifiable entity in the NIOSH organization chart. In late 2005, NIOSH for the first time designated an executive staff member—Dr. Güner Gürtunca, director of the Pittsburgh Research Laboratory—to serve as the program manager of the Hearing Loss Research Program. Although Dr. Gürtunca and another senior staff member are now expected to monitor and guide the overall program effort, the matrix nature of the Hearing Loss Research Program means that the program manager does not control its budget or program portfolio. The program’s funding level is the sum of the financial resources that individual NIOSH organizational units decide to apply to work on hearing loss prevention or noise control activities. The activities of the intramural program and the equivalent of about 30 professional staff members who carry it out are distributed unequally across three units located in Cincinnati and one in Pittsburgh. The selection and management of extramural projects is based in Atlanta. The committee was also conscious of the small size of the Hearing Loss Research Program budget. During the period under review, the program’s intramural funding grew from approximately $1.9 million in fiscal year (FY) 1997 to $5.2 million in FY 2005, and its extramural funding from $0.6 million to $2.3 million.

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Hearing Loss Research at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health The total NIOSH budget for FY 2005 was $286 million. By comparison, the FY 2005 budget for the National Institute on Deafness and Other Communication Disorders (NIDCD) in the National Institutes of Health (NIH) was $394.3 million. Of this, research on hearing comprised more than $176 million of the extramural budget of $340.9 million, and roughly 62 percent of the $34 million budgeted for intramural research projects (Rotariu, 2006a,b). The portfolio, staffing, and funding levels for the Hearing Loss Research Program are also shaped by congressional direction as to the amount of the NIOSH budget that is to be applied to mining safety and health. For FY 2005, the NIOSH Mining Safety and Health Research Program had a budget of $30.7 million and the equivalent of about 260 full-time staff members (NIOSH, 2006h). Approximately $3.6 million was allocated to intramural mining-focused activities (many related to underground coal mining) that are considered to be part of the Hearing Loss Research Program (NIOSH, 2006d). This work accounted for 69 percent of the Hearing Loss Research Program’s intramural funding for that year and 39 percent of about 40 full-time equivalents (FTEs) (15.5 positions). Although the NIOSH mining program no longer carries a separate line item in the federal budget, Congress has directed NIOSH to maintain its current level of research effort in this area. For the Hearing Loss Research Program, this means in practical terms that the program benefits from funding supporting work related to noise control and prevention of hearing loss in the mining sector, but the program does not have discretion to redirect these funds to any of the program’s other activities, which have only a small budget to address the broad goals of the program. OTHER FACTORS AFFECTING THE HEARING LOSS RESEARCH PROGRAM Another important factor that the committee came to understand over the course of its information gathering is the degree to which the Hearing Loss Research Program is currently undergoing change as part of NIOSH’s reorganization effort in conjunction with the second decade of NORA (NIOSH, 2006g), as well as by virtue of its self-scrutiny in preparation for this committee’s evaluation. As noted earlier, the program identified new research goals and named new leadership in 2005 as it prepared for this evaluation. Both the name of the program itself and the name of one of its four research goals have been modified since the evaluation began. The committee notes that the revised program name—Hearing Loss Research Program—seems to imply a narrower scope than the original name, Hearing Loss Prevention Program. While the program intends to develop a strategic plan, it has deferred that activity until the conclusion of this evaluation. A recently increased emphasis on transferring the products of NIOSH re-

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Hearing Loss Research at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health search into workplace application is also important to note. The Office of Research and Technology Transfer was organized in 2004 to help the agency’s scientific investigators better bridge the gap between concept and workplace adoption. ASSESSMENT OF RELEVANCE The committee recognizes that hazardous noise exposure and occupational hearing loss represent an important, and underrecognized, threat to the health and safety of U.S. workers in a variety of industries. Although recent data are not available, NIOSH has estimated that at least 4 million workers in the United States may be exposed at work to noise levels that put them at risk of hearing loss (NIOSH, 1998a). NIOSH also has estimated that 9 million workers (some of whom may be among those exposed to hazardous noise) could be at risk as a result of exposure to ototoxic chemicals (NIOSH, 2005d). At present, most hearing loss that results from occupational exposures is irreversible, and poor hearing can compromise both safety and quality of life. In evaluating the relevance of the work done by the NIOSH Hearing Loss Research Program, the committee has assessed the degree to which the program has led and carried out research in aspects of occupational hearing loss and noise control most relevant to improvements in workplace protection. If available, surveillance data regarding the nature and extent of the U.S. occupational hearing loss problem would form the basis for identifying priorities and targeting research. The public health approach would direct research efforts toward questions with the most potential to bring benefit to those industrial sectors or special workforce groups with the largest number of workers at risk, the highest risk of occupational hearing loss, or the greatest exposure to its risk factors. Unfortunately, no comprehensive effort to assess the extent of hearing loss among U.S. workers has been carried out for decades. In the absence of such data, both NIOSH and the evaluation committee have only information from more limited surveys, input from stakeholders, and expert judgment as a basis on which to prioritize the national and sector-specific needs in this area. The Hearing Loss Research Program has included the extramural work1 carried out on hearing loss as part of its program for the purposes of this evaluation. For about a decade, NIOSH has followed the NIH model for administering its 1 Extramural work for the purposes of this report refers to research conducted by investigators outside NIOSH using funding from the Office of Extramural Programs. It does not include work carried out through contracts or cooperative research and development agreements (CRADAs).

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Hearing Loss Research at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health extramural research program. NIOSH develops extramural programs “based on the NORA agenda, r2p [research to practice] initiatives, congressional mandates, and other emerging occupational safety and health priorities. The strategic plans of the individual NIOSH research programs will also influence extramural programs as they are developed and become more prominent in driving the research agenda” (NIOSH, 2005e). Proposals are evaluated for scientific merit by independent panels of experts, and meritorious proposals receive secondary programmatic review by a committee of senior NIOSH scientists. As the result of a “firewall” between intramural programs and the extramural funding selection process, investigators and planners within the intramural program have had little control over the selection of extramural research. The sections that follow review the four NIOSH Hearing Loss Research Program research areas in turn, providing the committee’s findings with regard to the relevance of the research completed or under way. (Committee evaluation of NIOSH’s targeting of new research is discussed in Chapter 3.) At the end of the review of the four research areas, the committee discusses the relevance of the program as a whole, and provides its quantitative and qualitative evaluation. Research Goal 1: Contribute to the Development, Implementation, and Evaluation of Effective Hearing Loss Prevention Programs Goals and Objectives NIOSH described three objectives for Research Goal 1: (1) providing authoritative, data-driven recommendations and guidelines; (2) developing and/or evaluating hearing loss prevention program “best practices”; and (3) developing, evaluating, and disseminating model training methods, materials, and tools. Each of these areas of effort can have an important role in either developing or synthesizing and conveying research results to minimize workplace exposure to hazardous noise. Thus, the committee found these objectives to be highly relevant to the overall aim of reducing work-related hearing loss. The activities carried out under this research goal are important to disseminating and applying information developed across the entire Hearing Loss Research Program, providing an important means of transfer to the workplace setting. Planning and Production Inputs Several important research planning efforts have guided the development of the agenda for this research area over the past decade. Of these, the most important have been “A Proposed National Strategy for the Prevention of Noise-

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Hearing Loss Research at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health Induced Hearing Loss” in 1988 (NIOSH, 1988), which set a course for the program until Criteria for a Recommended Standard: Occupational Noise Exposure (NIOSH, 1998a) was issued in 1998, and the NORA hearing loss prevention initiative in 2001. Most recently, a Futures Workshop was held in April 2005 to plan for the next decade. The Hearing Loss Research Program’s current objectives and work areas bear a reasonable relationship to the earlier planning activities. For example, NIOSH is clearly making efforts to address the two recommendations most closely related to this program area described in the NORA hearing loss initiative of 2001: (1) health communications research focused on training methods and (2) research to evaluate the effectiveness of compliance-driven hearing loss prevention programs. Each of the three planning efforts involved some stakeholder input, and the committee found that research in this program area reflects consistent efforts to develop working relationships with external partners in conducting activities and developing products. The committee recommends, however, that NIOSH expand the base of experts and stakeholders to whom it turns for advice and input to increase both the breadth of the disciplines involved and the depth of the scientific and programmatic expertise of these advisers. The facilities available for this research area include two audiometric suites, an education and training laboratory, and a mobile audiometric research facility. Since 1997, the financial and staffing resources allocated to this research area have increased. The number of personnel working on projects within this program area, as represented by the number of FTEs, has increased from roughly three to almost eight, and intramural funding has grown from $498,768 to $1,132,932 (see Table 2-2). Although this growth is encouraging, the committee believes that this level of support is not adequate given the importance of and need for the work of this research area. The committee also notes that while the program area has good staffing in audiology and psychology, it lacks the epidemiologic expertise to accomplish the necessary evaluation of the effectiveness of its activities and surveillance for occupational hearing loss and hazardous noise exposure, as discussed further below. Funding from the NIOSH extramural program expended on projects related to Research Goal 1 has fluctuated over the last decade, from a high in FY 2000 of $559,620 to a low in FY 2004 of $68,612. The funding levels reflect expenditures for from one to three ongoing projects at different times during that period. Activities and Outputs NIOSH has undertaken many activities categorized as part of this program area, distributed among the 10 specific areas listed in Table 2-1 and, as a result, has generated many useful publications and products for the field (NIOSH, 2005f).

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Hearing Loss Research at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health TABLE 2-2 NIOSH Hearing Loss Research Program Budget and Staffing by Research Goals   FY 1997 FY 1998 FY 1999 FY 2000 Research Goal 1: Contribute to the Development, Implementation, and Evaluation of Effective Hearing Loss Prevention Programs Intramural $498,768 $443,552 $882,679 $888,571 FTEs 3.14 5.44 5.99 5.21 Extramural $195,806 $254,171 $434,103 $559,620 Interagency Agreements $0 $0 $0 $0 Contracts $21,800 $214,829 $258,329 $257,680 CRADAs None None None None Research Goal 2: Reduce Hearing Loss Through Interventions Targeting Personal Protective Equipment Intramural $141, 234 $0 $271,744 $339, 613 FTEs 1.90 0.00 4.30 3.05 Extramural $0 $38,897 $143,777 $0 Interagency Agreements $0 $0 $0 $50,000 Contracts $0 $0 $0 $0 CRADAs None None None None Research Goal 3: Develop Engineering Controls to Reduce Noise Exposure Intramural $929,618a $540,419 $466,104 $862,243 FTEs 14.64a 6.75 8.8 11.97 Extramural $0 $0 $0 $0 Interagency Agreements $0 $0 $0 $100,000 Contracts $0 $0 $0 $15,000 CRADAs None None None None Research Goal 4: Improve Understanding of Occupational Hearing Loss Through Surveillance and Investigation of Risk Factors Intramural $199,448 $164,122 $108,434 $226,573 FTEs 2.75 2.30 1.60 2.33 Extramural $436,599 $614,942 $977,888 $753,308 Interagency Agreements $288,888 $288,888 $288,888 $288,888 Contracts $0 $0 $0 $0 CRADAs HearSāf HearSāf HearSāf HearSāf NOTE: CRADA, collaborative research and development agreement; FTE, full-time equivalent. aThe 1997 FTE figure shown in the table, which is derived from a NIOSH database, differs from the 1997 staffing level recalled by program and budget managers (3 FTEs) (Lotz, 2006b). SOURCE: NIOSH, 2006a,b,c,d.

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Hearing Loss Research at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health FY 2001 FY 2002 FY 2003 FY 2004 FY 2005 $1,059,249 $901,939 $785,508 $1,166,467 $1,132,932 4.56 3.94 3.39 3.45 7.85 $271,729 $355,700 $110,625 $68,612 $483,270 $0 $0 $0 $0 $0 $282,680 $257,680 $264,280 $262,030 $92,851 None None None None None $434,802 $351,846 $731,164 $875,273 $724,586 3.70 3.90 5.10 7.95 8.10 $380,196 $352,879 $0 $0 $183,679 $75,000 $50,000 $113,000 $55,000 $133,000 $0 $73,000 $0 $24,570 $0 None None None None Earphone $1,477,267 $1,856,948 $1,753,007 $2,086,163 $2,454,984 15.02 10.3 17.23 21.1 16.27 $50,000 $215,158 $225,600 $141,400 $0 $0 $0 $0 $0 $0 $117,250 $127,250 $187,250 $191,800 $145,000 None None None None None $653,150 $944,926 $976,153 $639,372 $453,457 4.55 6.80 7.84 6.22 3.45 $1,089,905 $1,381,223 $1,190,484 $1,488,404 $1,660,459 $288,888 $288,888 $288,888 $359,888 $359,888 $33,750 $58,750 $158,543 $142,800 $0 None None None None Impulse meter

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Hearing Loss Research at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health are enabling BLS to provide annual data on the number of cases of recordable hearing loss in various industrial sectors. This is a welcome step toward documenting, on a national level, the magnitude of the hearing health problem among workers. The data will also provide a means to monitor patterns of workers’ hearing losses over time. Previously, data on occupational hearing loss were being reported on a regular basis only by the State of Michigan (see Rosenman and Panasuk, 2004; see also NIOSH, 2004). Beginning in 1992, the Hearing Loss Research Program provided technical and financial support to Michigan to establish a case ascertainment system for noise-induced hearing loss through the Sentinel Event Notification System for Occupational Risks (SENSOR). The Michigan program includes referral assistance for companies that do not have their own hearing conservation programs. The Michigan data are a mix of reports of standard threshold shifts and hearing tests showing thresholds that meet specific criteria; the data come from employers’ hearing conservation programs and reports from audiologists and otolaryngologists. The newly available national data and the Michigan data are welcome information, but the epidemiologic value of both datasets is somewhat diminished by their case definitions and denominators. These data collection systems do not make use of traditional epidemiologic definitions of hearing loss and methods to capture person-level data to measure the true incidence of hearing loss in workers. Another concern is that the proportion of hearing loss cases that are identified may vary among industries. The committee commends the Hearing Loss Research Program for its success in raising awareness of the need to document the occurrence of hearing loss in workers, but the committee also emphasizes that it is essential for the program to have epidemiologic expertise fully integrated into its work on surveillance to help maximize the utility of the data collected. Standards and guidelines The Hearing Loss Research Program’s work on ototoxic chemicals is contributing to wider attention to potential ototoxic hazards of workplace exposure to certain chemicals, alone or in combination with noise. As noted in conjunction with Research Goal 1, the U.S. Army refers to NIOSH research on ototoxicity in a fact sheet (USACHPPM, 2003) and has incorporated consideration of exposure to ototoxins in its hearing conservation program (Department of the Army, 1998). The Hearing Loss Research Program has also worked with various organizations to help prepare guidelines on best practices related to ototoxic substances. For example, the American Conference of Governmental Industrial Hygienists (ACGIH) notes ototoxic chemical hazards in the noise section of its Threshold Limit Values and Biological Exposure Indices (ACGIH, 2003). Occupational ototoxic hazards are addressed outside the United States in worker

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Hearing Loss Research at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health compensation legislation in Australia and Brazil and in worker health and safety standards, such as a 2003 directive issued by the European Parliament and the Council of the European Union (2003). Explicit links to NIOSH and the Hearing Loss Research Program are not necessarily evident, but with the extensive publication record of program researchers, it seems reasonable to credit them with some influence on these developments. Summary assessment The Hearing Loss Research Program cannot be expected to demonstrate the impact of the work conducted as part of Research Goal 4 on the basis of outcomes such as reductions in the incidence rate, numbers of cases, or severity of occupational hearing loss. The committee does, however, consider contributions that the work makes to the knowledge base on occupational hearing loss to be important intermediate outcomes. These contributions are essential steps along the pathway to effective public policies and improved public health outcomes. The program’s work on ototoxicity is widely cited by other researchers and is reflected in the hearing conservation policies of some organizations. Support for OSHA’s implementation in 2004 of separate reporting of recordable occupational hearing loss has contributed to generating at least a minimal form of national surveillance data, which NIOSH and other researchers will be able to use to learn more about contemporary patterns of occupational hearing loss. The committee considers it very likely that application of knowledge generated by the program about the effects of chemical exposures and impulsive noise on hearing will lead to greater awareness of these effects and to improved worker health and safety in the future. For the program’s work on genetic and age-related aspects of hearing loss, however, some contribution to basic knowledge regarding hearing health is possible, but work being done in these areas seems unlikely to contribute to knowledge regarding noise exposure and hearing loss among workers. OVERALL EVALUATION OF THE IMPACT OF THE HEARING LOSS RESEARCH PROGRAM As it did with its assessment of the relevance of the Hearing Loss Research Program, the committee’s evaluation of impact reflects consideration of the program as a whole as well as its components, as represented by the four research goals. It was not possible to assess the program’s impact on the basis of changes in the incidence or severity of occupational hearing loss or in noise exposure experienced by workers. Indeed, the lack of such data on these end outcomes is one of the major challenges of the field. The committee turned to what it considered intermediate outcomes to make its assessment of impact.

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Hearing Loss Research at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health In making its assessment of the impact of the Hearing Loss Research Program, the committee considered how to combine the varied evidence of the program’s impact. The conclusion reached was that the committee’s rating should rest primarily on the degree to which evidence of positive impact could be observed. Areas of limited impact were not allowed to detract on an equally weighted basis from more successful efforts. The committee found that the Hearing Loss Research Program has made contributions through publication of findings from intra- and extramural research in the peer-reviewed scientific literature, collaborative development of technologies for application in the workplace, collection and publication of resource materials for technical and lay audiences, development and delivery of educational programs, participation in the development of various national and international voluntary standards concerning noise and hearing loss, development of recommendations on noise exposure limits and hearing loss prevention practices, and consultation and collaboration with regulatory agencies. It is clear to the committee that many of the program’s work products have been adapted or adopted for use by business, labor, and occupational health professionals. Examples include adoption by the U.S. Army of the 1998 NIOSH recommendations for an 85 dBA 8-hour time-weighted average as constituting a 100 percent daily noise dose and use of a 3-dB exchange rate for determining trade-offs in the level and duration of noise exposure, and acceptance of the NIOSH recommendation for a 3-dB exchange rate and an 85-dB exposure limit by major professional organizations. Stakeholders reported widespread use of Preventing Occupational Hearing Loss—A Practical Guide (NIOSH, 1996) and the hearing protector compendium. The committee found that the Hearing Loss Research Program has made important contributions to increasing knowledge about the real-world performance of hearing protection devices, improving the methods and tools for assessing hearing protector attenuation, and encouraging relevant agencies and organizations to modify regulations and other guidance concerning hearing protector attenuation. The program provided support for establishing the feasibility of MSHA’s listed engineering noise controls, contributed to rule making requiring noise control as the primary focus of occupational hearing loss prevention in mines, and contributed to international standards and heightened awareness by some U.S. organizations of the ototoxicity of several chemicals used widely in industry. In addition, the program encouraged the implementation by OSHA of new procedures for reporting occupational hearing loss on the OSHA 300 log, which will provide some basis for monitoring national patterns of workplace hearing loss. The program’s participation in health hazard evaluations presents an opportunity to inform workers and employers about workplace noise hazards and to make rec-

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Hearing Loss Research at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health ommendations for corrective steps that are based on the program’s work in various areas, but in practice, the impact of these site-specific reviews is likely to be limited. The committee sees the program as being, despite its small size, a unique and essential resource in efforts to protect workers’ hearing. With no authority to establish or enforce regulations concerning workplace noise exposure and hearing conservation, some of the program’s impact must be achieved through activities such as consultation with regulatory agencies, principally OSHA, MSHA, and EPA, and with employers, workers, equipment manufacturers, and occupational safety and health professionals. The impact of contributions in the form of formal and informal consultation, advice, and recommendations may be difficult to document but should not be discounted. Nevertheless, the committee found that the Hearing Loss Research Program has not given sufficient attention to consideration of performance criteria related to intermediate or end outcomes. Developing such criteria could aid the program in identifying desired forms of impact, targeting efforts toward achieving those outcomes, and assessing progress. A related concern is the need for more attention to evaluation of the effectiveness of the program’s activities and the view that some of the evaluation efforts that are being made could be more useful if they were based on end outcomes, such as reducing the incidence or severity of occupational hearing loss, or on achieving important intermediate outcomes, such as sustained improvement in the use of hearing protection or in the management of hearing loss prevention programs. Evaluation based on changes in knowledge, attitudes, or behavioral intentions is not sufficient. The committee is also concerned that too little attention has been given to developing data on the incidence and severity of occupational hearing loss and the levels and extent of noise exposure among workers. Such data are essential for determining the most meaningful impacts of the work of the Hearing Loss Research Program. Developing and maintaining surveillance systems present substantial challenges, but well-designed longitudinal research studies could provide not only valuable descriptive information on noise exposure and hearing loss but also the opportunity to test the effectiveness of recommended hearing loss prevention measures. The program may also be missing the opportunity to help build a stronger scientific basis for aspects of occupational hearing loss prevention. With a few notable exceptions, researchers in the Hearing Loss Research Program have made only limited contributions to the peer-reviewed research literature. Presentations and other kinds of publications are important contributions, but they cannot take the place of formal documentation of research results. Timely publication of research results and conference proceedings helps keep the wider scientific community informed about the program’s work and encourages other researchers to test

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Hearing Loss Research at NIOSH: Reviews of Research Programs of the National Institute for Occupational Safety and Health and build on findings from the NIOSH program. Relying on unpublished analyses as a foundation for important policy recommendations may, in the long run, weaken the credibility of those recommendations. The program’s narrow set of activities in engineering noise controls appears to have had a limited impact, mostly in mining, and may have limited prospects for future impact, especially in other industrial sectors. Development of the database on noise emission levels of powered hand tools is a source of concern because of the lack of rigor in the laboratory operations and the lack of attention to the content and performance of the online database. The committee also considers the student projects to design noise controls as offering little prospect for impact on noise exposures. Furthermore, work regarding genetic and age-related aspects of hearing loss is likely to make some contribution to basic knowledge in these areas, but will not readily contribute to knowledge regarding noise exposure and hearing loss among workers. On the basis of its review, the committee has assigned the NIOSH Hearing Loss Research Program a score of 4 for impact, notwithstanding significant short-comings in some aspects of the program. This score reflects a judgment that the Hearing Loss Research Program has made a moderate contribution on the basis of well-accepted intermediate outcomes, has generated important new knowledge, and is engaged in transfer activities (see Box 2-3). This score reflects the committee’s assessment that the program has had identifiable and worthwhile impact that should not be discounted because of lesser degrees of impact from some aspects of the program. BOX 2-3 Scale for Rating Program Impact 5 = Research program has made a major contribution to worker health and safety on the basis of end outcomes or well-accepted intermediate outcomes. 4 = Research program has made a moderate contribution on the basis of end outcomes or well-accepted intermediate outcomes; research program generated important new knowledge and is engaged in transfer activities, but well-accepted intermediate outcomes or end outcomes have not been documented. 3 = Research program activities or outputs are going on and are likely to produce improvements in worker health and safety (with explanation of why not rated higher). 2 = Research program activities or outputs are going on and may result in new knowledge or technology, but only limited application is expected. 1 = Research activities and outputs are NOT likely to have any application. NA = Impact cannot be assessed; program is not mature enough.

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