SUPPLEMENTARY INFORMATION:

I. Background of This Rulemaking

The Longshore and Harbor Workers' Compensation Act (LHWCA), 33 U.S.C. 901-950, provides for the payment of compensation to employees for disability or death from injury arising out of and in the course of employment. Hearing loss claims represent a substantial portion of claims filed under the LHWCA. Section 8(c)(13) of the LHWCA, 33 U.S.C. 908(c)(13), specifically addresses compensation for loss of hearing and establishes that audiograms meeting certain criteria provide presumptive evidence of the amount of hearing loss sustained.

Medical testing evidence is essential to evaluating benefits entitlement in virtually every hearing loss claim. Under Section 8(c)(13)(C), an audiogram is presumptive evidence of the amount of hearing loss sustained as of the date thereof, only if: (i) such audiogram was administered by a licensed or certified audiologist or a physician who is certified in otolaryngology, (ii) such audiogram, with the report thereon, was provided to the employee at the time it was administered, and (iii) no contrary audiogram made at that time is produced.

The Department's implementing regulations are currently codified at 20 CFR 702.441. Section 702.441(d) provides that in determining the loss of hearing under the Act, evaluators shall use the criteria for measuring and calculating hearing impairment as published and modified from time-to-time by the American Medical Association in the Guides to the Evaluation of Permanent Impairment, ( printed page 37365) using the most currently revised edition of this publication. In addition, the audiometer used for testing must be calibrated according to current American National Standard Specifications for Audiometers. Audiometer testing procedures required by hearing conservation programs pursuant to the Occupational Safety and Health Act of 1970 should be followed (as described at 29 CFR 1910.95 and appendices).

Since the current regulations were established, medical technology and practice have evolved significantly. Objective testing methods such as Auditory Brainstem Response (ABR), Auditory Steady State Response (ASSR), Otoacoustic Emissions (OAE) and other screening have become more widely available and are used in clinical settings. These objective tests measure physiological responses to sound stimuli and do not rely on subjective patient responses, unlike traditional pure-tone audiometry (audiograms). Stakeholders have expressed interest in having the regulations updated to consider whether objective testing methods should be used in addition to traditional audiograms based on their relative reliability and validity.

OWCP is now considering updating the standards for administering hearing tests and the relative weight given to different testing methodologies. Recognizing that qualifying audiograms constitute presumptive evidence of hearing loss, OWCP seeks input on how objective testing methods may be used within this statutory framework, including to resolve discrepancies between multiple audiogram tests or as supporting or rebuttal evidence. OWCP's goal is to adopt regulations that reflect current medical technology and practice while ensuring accurate, reliable, and fair determinations of hearing loss.

II. Information Request

OWCP requests input from audiologists, otolaryngologists, medical professionals, medical associations, employees, employers, insurance carriers, trade associations, and other interested parties on the comparative reliability and validity of different hearing testing methods and current best practices for evaluating occupational hearing loss.

When responding, please:

• Address your comments to the topic and question number whenever possible. For example, you would identify your response to Question 1 as “A.1.”
• Provide your rationale for your views.
• Provide sufficient detail in your responses to enable proper agency review and consideration. OWCP wants to fully understand your answers and any recommendations you make.
• Identify the information on which you rely. Please provide specific examples. Include applicable data, studies, or articles regarding standard professional practices, availability of technology, and costs.

OWCP invites comment in response to the specific questions posed below and encourages commenters to include any related cost and benefit data. OWCP is especially interested in issues related to the economic impact on small entities as defined by the Regulatory Flexibility Act, 5 U.S.C. 601(6).

A. Reliability and Validity of Audiograms Versus Objective Testing Methods

1. What is the comparative reliability of pure-tone audiometry (audiograms) versus objective tests (ABR, ASSR, OAE, etc.) in accurately measuring occupational hearing loss? Please provide peer-reviewed studies or data supporting your position.

2. What is the comparative validity of pure-tone audiometry versus objective tests in measuring functional hearing loss and disability? Please provide specific evidence.

3. Are objective tests (ABR, ASSR, OAE, etc.) less susceptible to invalid results due to patient effort, malingering, or exaggeration compared to audiograms? What evidence from peer-reviewed literature supports this?

4. In cases where audiogram results and objective test results differ, which testing method has been shown to more accurately reflect actual hearing loss? Please cite specific studies or clinical evidence.

5. What are the known limitations of objective testing methods (ABR, ASSR, OAE, etc.) in evaluating occupational hearing loss, particularly noise-induced hearing loss? Are there circumstances where audiograms provide more accurate or relevant information than objective tests?

6. Do objective tests measure the same aspects of hearing function as audiograms? How do the measurements correlate, and what does the peer-reviewed literature show about their relationship?

B. Clinical Use and Professional Standards for Objective Testing

7. For what purposes are objective tests (ABR, ASSR, OAE, etc.) currently used in clinical audiology practice? Are they routinely used to quantify hearing loss for disability or impairment determinations?

8. Are there other workers' compensation programs, disability determination systems, or legal jurisdictions (domestic or international) that currently use objective testing methods (ABR, ASSR, OAE, etc.) for hearing loss evaluations? If so, what has been their experience with these methods?

9. What professional standards or guidelines exist for using objective tests to evaluate occupational hearing loss? Please identify specific standards published by organizations such as the American Academy of Audiology, American Speech-Language-Hearing Association, or other recognized professional bodies.

10. How widely available are objective testing methods (ABR, ASSR, OAE, etc.) across different geographic regions and practice settings? What percentage of audiologists or otolaryngologists have access to this equipment?

11. What are the current costs of objective testing compared to traditional audiometry? Please provide specific cost data including equipment costs, per-test costs, and any other relevant economic information.

C. Test Administration Standards and Quality Control

12. If OWCP were to incorporate objective testing methods into the regulations, what specific quality standards should be required for equipment calibration, testing protocols, and interpretation? Please identify established professional standards that could be referenced.

13. What qualifications, training, or certifications should be required for personnel administering and interpreting objective tests (ABR, ASSR, OAE, etc.)?

14. Are the current audiogram administration standards referenced in 20 CFR 702.441(d) (calibration per American National Standard Specifications for Audiometers and procedures per 29 CFR 1910.95) adequate to ensure reliable results, or should additional standards be adopted?

15. What quality control measures are necessary to ensure the validity of hearing tests and prevent invalid or unreliable results?

16. Should OWCP require audiograms to be administered following a set of contralateral masking rules implemented in France and described extensively in French audiometry guidelines? Are there alternative standards OWCP should consider? ( printed page 37366)

D. Weighting and Use of Different Testing Methods

17. If both audiometric and objective testing are performed and the results differ, what criteria should be used to determine which result is more reliable? Should one type of test be given greater weight, and if so, based on what evidence? When does objective testing rebut the presumption of hearing loss based on audiometric testing?

18. Are there specific circumstances where objective testing should be required in addition to audiometry ( e.g., when results are inconsistent, when test validity is questioned)? What should trigger the need for additional testing?

19. Should objective tests be used as primary evidence of hearing loss, confirmatory evidence, or only in specific circumstances? What does the clinical literature support?

E. Measuring and Calculating Hearing Impairment

20. Does the current edition of the AMA Guides to the Evaluation of Permanent Impairment provide an appropriate methodology for calculating hearing impairment based on audiometric results? Are there specific aspects that are problematic for LHWCA hearing loss claims?

21. Can objective test results (ABR, ASSR, OAE, etc.) be meaningfully converted into the hearing impairment percentages calculated under the AMA Guides methodology? If so, how? Please provide specific methodologies with supporting evidence.

22. Are there validated alternative methods for calculating hearing impairment from objective test results? Please identify specific methodologies with peer-reviewed support.

23. The AMA Guides use specific frequencies (500, 1000, 2000, and 3000 Hz) to calculate hearing impairment. Is this appropriate for occupational noise-induced hearing loss, or should different frequencies be weighted? What does the research literature support?

24. When objective test results (ABR, ASSR) are converted to frequency-specific threshold estimates in dB HL, how closely do they correlate with audiometric thresholds in adults with occupational noise-induced hearing loss? What degree of variation is considered normal, and how should discrepancies be resolved for impairment rating purposes?

F. Economic Impact and Feasibility

25. What would be the economic impact on employers, insurance carriers, and medical providers of requiring or allowing objective testing methods? Please provide specific cost estimates.

26. What would be the economic impact of potential changes to testing standards on small entities (small employers, small medical practices)? Are there access or cost barriers that would disproportionately affect small entities?

27. What is the technological and economic feasibility of implementing updated hearing loss testing standards, including the potential use of objective testing methods?

G. OTC Hearing Aids: Technology and Capabilities

28. Should OWCP consider the appropriateness of OTC hearing aids as appropriate compensation in hearing loss cases? What should OWCP consider when evaluating OTC versus prescription hearing aids in terms of affordability, ease of use, and capabilities?