Some Thoughts on the Future of Audiology

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Some Thoughts on the Future of Audiology David Zapala, Ph.D., Associate Professor, Mayo Clinic in Florida Sumitrajit Dhar, Ph.D., Professor, Northwestern University Don Nielsen, Ph.D., Consultant, Northwestern University James W.

1 Some Thoughts on the Future of Audiology David Zapala, Ph.D., Associate Professor, Mayo Clinic in Florida Sumitrajit Dhar, Ph.D., Professor, Northwestern University Don Nielsen, Ph.D., Consultant, Northwestern University James W. Griffith, Ph.D., Assistant Professor, Northwestern University Samantha Kleindienst -Robler, Au.D., Ph.D., Norton Sound Health Corporation, AK Deborah L. Carlson, Ph.D., University of Texas Medical Branch, Galveston, TX 2017 MFMER slide-1

2 Acknowledgements NIDCD grant R21-R33 DC Accessible and Affordable Health Care The Knowles Center, Northwestern University James Russell and Martha Crawford Endowed Clinical Research Fellowship in Otolaryngology at Mayo Clinic in Florida Parts of this presentation were presented to the Institute of Medicine Committee on Accessible and Affordable Healthcare 2017 MFMER slide-2

3 The opinions expressed in this talk are strictly my own. They do not reflect the policies or opinions of: NIH or NIDCD NASEM Mayo Clinic My co-investigators 2017 MFMER slide-3

4 The Baby Boomer Bump 2000 Census 25,000,000 20,000, U.S. Population 15,000,000 10,000,000 5,000,000 Baby Boomer Bump Age in Years 2017 MFMER slide-4

5 The Baby Boomer Bump 2010 Census 25,000, ,000, U.S. Population 15,000,000 10,000,000 5,000,000 Baby Boomer Bump Age in Years 2017 MFMER slide-5

6 The Baby Boomer Bump 2015 Projection 25,000, ,000, Projection U.S. Population 15,000,000 10,000,000 5,000,000 Baby Boomer Bump Age in Years 2017 MFMER slide-6

7 The Baby Boomer Bump 2015 Projection U.S. Population 25,000, ,000, Projection 15,000,000 10,000,000 5,000, Age in Years 2017 MFMER slide-7

8 Prevalence of Communicatively Significant Loss (2010) Prevalence: 1 in year olds (6,000,000) 1 in year olds (8,500,000) 3 in year olds (8,900,000) Served by 1300 ENTs 1300 Audiologists 600 Neurotologists / Otologists 900 Instrument Dispensers 2017 MFMER slide-8

9 Prevalence of Communicatively Significant Loss (2010) Prevalence: 1 in year olds (6,000,000) 1 in year olds (8,500,000) In 32010: in 4 ~ year Seniors olds / (8,900,000) Healthcare Provider Served In 2015: by ~6850 Seniors / Healthcare Provider 1300 ENTs In : Audiologists ~8000 Seniors / Healthcare Provider 600 Neurotologists / Otologists 900 Instrument Dispensers 2017 MFMER slide-9

10 Accessibility and Affordability: Part 1 - Time Line 2009: National Institute Deafness and Communicative Disorders Report on the Accessibility and Affordability of Healthcare 2015: President's Council of Advisors on Science and Technology (PCAST) Report investigated age-related mild to moderate hearing loss 2016: National Academy of Sciences, Engineering and Medicine (NASEM) Health Care for Adults: Priorities for Improving Access and Affordability 2016 / 2017: Federal Drug Administration (FDA) Eliminated Medical Waiver System Workshop on Health and Technology 2016/ 2017: Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) Over the Counter (OTC) Aid Act 2016 / 2017: Consumer Electronics Association (CEA) Standards and performance measurements for PSAPs and OTC HAs 2017 MFMER slide-10

11 2017 MFMER slide-11

12 Only 25% of consumers can accurately assess the degree of hearing loss, and they don t know if they have the loss in one or both ears. said Bob Barber, and Arizona hearing aid dispenser with Miracle Ear MFMER slide-12

Miracle Audiologists also uncover serious Ear.

according to Tucson based audiologist Judy Huch.

13 Only 25% of consumers can accurately assess the degree of hearing loss, and they don t know if they have the loss in one or both ears. said Bob Barber, and Arizona hearing aid dispenser with Miracle Audiologists also uncover serious Ear. nerve problems, infections and tumors during exams, according to Tucson based audiologist Judy Huch. People might say: OK, you found 3 tumors in 20 years she said. But for me, missing one brain tumor is one too many MFMER slide-13

14 Humes et al, 2017 aids make a difference aids similar to OTC hearing aids have almost as good of outcomes as those fit by audiologists using best practices Audiologists have the best Outcomes 2017 MFMER slide-14

15 Accessibility and Affordability: Part 2 ADA: Audiology Patient Choice Act Audiologists as Medicare Physicians Medicare pays for hearing tests without physician referral ASHA / AAO: Medicare Audiology Services Enhancement Act Plan of care will be developed by the audiologist and reviewed and signed periodically by a physician. Medicare pays for hearing tests with physician referral AAA: Direct Access??? 2017 MFMER slide-15

16 What Should Insurance / Medicare Pay For...? Audiology Healthcare Practitioner / Medical Model Wellness Care Consumer / Market Model Disease Detection, Diagnosis & Progression Auditory Rehabilitation following disease Auditory Rehabilitation for Age & lifestyle hearing problems Conservation Consumer Electronics & Internet of things Product Design 2017 MFMER slide-16

17 Note Pressures on Healthcare Definition Audiology: Individualized Care Disease Related (Medical Model) devices as commodity items (Consumerism/Market Model) 2017 MFMER slide-17

18 What does the Community Need from Audiology? (What does the Market Need?) 1. Prevention of hearing impairment and associated communicative disorders on a societal level 2. Detection and assessment of hearing impairment and associated communicative disorders 3. Detection and referral for treatment of diseases causing hearing impairment 4. Aural Rehabilitation 5. Prognosis: individualized future risk for hearing impairment and how to mitigate 2017 MFMER slide-18

19 What does the Community Need from Audiology? (What does the Market Need?) 1. Prevention of hearing impairment and associated communicative disorders on a societal level 2. Detection and assessment of hearing impairment and associated communicative disorders 3. Detection and referral for treatment of diseases causing hearing impairment 4. Aural Rehabilitation 5. Prognosis: individualized future risk for hearing impairment and how to mitigate 2017 MFMER slide-19

20 Models for Healthcare Delivery Option #1 Option #2 Option #3 Option #4 Impaired Person Impaired Person Impaired Person Primary Care provider Impaired Person Primary Care provider aid Audiologist aid Audiologist Audiologist Ear, Nose & Throat Provider aid aid 2017 MFMER slide-20

21 Which Model Has the Best Outcomes? Cost / Disease Dx? Cost / hearing aid? Cost / hearing benefit? Option #1 Option #2 Option #3 Option #4 Impaired Person Impaired Person Impaired Person Primary Care provider Impaired Person Primary Care provider aid Audiologist aid Audiologist Audiologist Ear, Nose & Throat Provider aid aid 2017 MFMER slide-21

22 Which Model Has the Best Outcomes? Cost / Disease Dx? Cost / hearing aid? Cost / hearing benefit? Option #1 Option #2 Option #3 Option #4 Impaired Person Impaired Person Impaired Person Primary Care provider Impaired Person Primary Care provider aid Audiologist aid Audiologist Audiologist Ear, Nose & Throat Provider aid aid 2017 MFMER slide-22

23 Ear Disease Prevalence (age >= 50 yrs) Cases / 1,000,000 Age related hearing loss Vestibular schwannoma Meniere s disease Sudden sensorineural hearing Cholesteatoma Otosclerosis Suppurative Acute OM Otitis externa Cerumen impaction ,900 3,060 4,000-1,000 2,000 3,000 4,000 5, MFMER slide-23

24 Diseases (age >= 50 yrs) Cases / 1,000,000 Age related hearing loss Vestibular schwannoma Meniere s disease Sudden sensorineural hearing loss Cholesteatoma Otosclerosis Suppurative Acute OM Otitis externa Cerumen impaction 10 1, ,060 5,460 4,000 20, , , , , MFMER slide-24

25 Which Model Has the Best Outcomes? Cost / diagnosis? Cost / hearing aid? Cost / hearing benefit? Option #1 Option #2 Option #3 Option #4 Impaired Person Impaired Person Impaired Person Primary Care provider Impaired Person Primary Care provider aid Audiologist aid Audiologist Audiologist Ear, Nose & Throat Provider aid aid 2017 MFMER slide-25

26 Which Model Has the Best Outcomes? Cost / diagnosis? Cost / hearing aid? Cost / hearing benefit? Option #1 Option #2 Option #3 Option #4 Impaired Person Impaired Person Impaired Person Primary Care provider Impaired Person Primary Care provider aid Audiologist aid Audiologist Audiologist Ear, Nose & Throat Provider aid aid 2017 MFMER slide-26

27 Health and Disease: What Conditions Should be Identified Prior to Aid Procurement? Kleindienst et al, (2016). Identifying and Prioritizing Diseases Important for Detection in Adult Healthcare. AJA 2017 MFMER slide-27

28 Health and Disease: What Conditions Should be Identified Prior to Aid Procurement? Audiology / PCP collaboration is important! Kleindienst et al, (2016). Identifying and Prioritizing Diseases Important for Detection in Adult Healthcare. AJA 2017 MFMER slide-28

29 Medical Home Concept Proscriptive Care? Physician determines when and which type of hearing care to pursue Why? Answer: recognition of systemic disease with auditory symptoms (?) Collaborative Care? Consumer / Patient driven direct access to audiology services with PCP notification / communication Also achieves recognition of systemic disease with auditory symptoms 2017 MFMER slide-29

30 Which Model Has the Best Outcomes? Cost / diagnosis? Cost / hearing aid? Cost / hearing benefit? Option #1 Option #2 Option #3 Option #4 Impaired Person Impaired Person Impaired Person Primary Care provider Impaired Person Primary Care provider aid Audiologist aid Audiologist Audiologist Ear, Nose & Throat Provider aid aid 2017 MFMER slide-30

31 2017 MFMER slide-31

32 Can Audiologists Assess Ear Disease Risk? >1500 Medicare eligible adults seeking relief from hearing loss Audiologist Evaluation Benign Suspected Ear Disease Aids / Communication Management Independent Assessment by Audiologists, Otolaryngology & Neurotology Physicians Zapala, et al. (2010) 2017 MFMER slide-32

33 Conclusion There was essentially no difference between Otolaryngologist and Audiologist decisions concerning who was or was not at risk for ear disease. Audiologists over- referred slightly Neurotologists and Audiologists had the same sensitivity for vestibular schwannoma 2017 MFMER slide-33

34 Which Model Has the Best Outcomes? Cost / diagnosis? Cost / hearing aid? Cost / hearing benefit? Option #1 Option #2 Option #3 Option #4 Impaired Person Impaired Person Impaired Person Primary Care provider Impaired Person Primary Care provider aid Audiologist aid Audiologist Audiologist Ear, Nose & Throat Provider aid aid 2017 MFMER slide-34

35 Consumer Ear Disease Risk Assessment (CEDRA) Questionnaire designed for hearing aid seeking consumers Asks questions about health status and ear disease symptoms Provides a prediction of ear disease risk in real time 2017 MFMER slide-35

36 Example Questions Overall Health Dizziness Balance Tinnitus Overall, how would you rate your health? How often do you have dizziness? How would you rate your balance? Do you have tinnitus, such as ringing, roaring, or cricket like sounds in your ears? Loss: Onset Fluctuation Asymmetry Did the hearing loss in either of your ears develop suddenly? Have you ever had a sudden permanent change in your hearing? Does your hearing change from day to day? Do you hear better in one ear than the other? When talking on a telephone, do you understand what people say better in one ear than the other? 2017 MFMER slide-36

37 Interim CEDRA Results Initial risk probability algorithm Developed from a cohort of 192 cases of disease and age related hearing loss Cross validated in a cohort of 54 similar cases Performance validation 90% of ear disease cases identified (10% Miss Rate) 71% of age related hearing loss cases accurately identified Sensitivity Specificity 2017 MFMER slide-37

38 Relative Performance of CEDRA AAO -75% 94% FDA -22% 82% Age / Noise Disease CEDRA (Criterion: <=4) -30% 87% -100% -50% 0% 50% 100% False Positive Rate (Red) / Hit Rate (Blue) 2017 MFMER slide-38

39 Relative Performance of CEDRA AAO -75% 94% FDA -22% 82% Age / Noise Disease CEDRA (Criterion: <=2) -61% 96% -100% -50% 0% 50% 100% False Positive Rate (Red) / Hit Rate (Blue) 2017 MFMER slide-39

40 Performance in Adults >= 50 Years 450, , ,943 No Disease Referrals / 1,000, , , , , , , ,143 Disease Miss rate 158,377 50,000-12,479 10,886 11, AAO FDA CEDRA 2017 MFMER slide-40

41 CEDRA Self Assessment of Ear Disease Risk is feasible but imperfect There is a cost in missed ear disease when consumers decide when they have ear disease. Is the cost worth governmental interference in the free market? 2017 MFMER slide-41

42 Standardizing Ear Disease Risk Assessment by Audiologists 2017 MFMER slide-42

43 Professional Ear Disease Risk Analytics (PEDRA) Structured Interview Simple Standardized Physical Examination Algorithmic Disease Detection Analytics Real-Time Estimate of Ear Disease Risk 2017 MFMER slide-43

44 Semi-Structured Interview History / Risk Factors Family History of Loss Ear Infections / Surgeries Exposures Noise Ototoxic Trauma General Medical Conditions Heart disease Diabetes Onset, progression, laterality of hearing loss and related symptoms Otologic Pain, pressure, fullness, Tinnitus Dizziness Neurologic Diplopia, Dysarthria, headache Constitutional Night fevers 2017 MFMER slide-44

45 Examination Inspection Otoscopic Check for facial asymmetry Test Data Basic Comprehensive Examination Pure tone air / bone SRT WR Immitance Analytics asymmetry calculation Age Sex Pure tone asymmetry (Zapala et al, 2012) Word Recognition Performance Modeling Acoustic Reflex Modeling 2017 MFMER slide-45

46 PEDRA Analytics Individualized reference values for: Word Recognition Acoustic Reflex Thresholds Estimated probability of Age Related Loss (p) = or 2:1000 cases 2017 MFMER slide-46

47 PEDRA / Mayo Audiology AAO -75% 94% FDA -22% 82% CEDRA (Criterion: >=4) -30% 87% Age / Noise Disease Audiologist Judgement / PEDRA -5% 96% -100% -50% 0% 50% 100% False Positive Rate (Red) / Hit Rate (Blue) 2017 MFMER slide-47

48 PEDRA / Mayo Audiology AAO -75% Goal: NIDCD Ear Disease Risk Scale All audiologists perform diagnostic tests FDA -22% with the same precision and referral accuracy CEDRA (Criterion: >=4) -30% 82% 94% 87% Age / Noise Disease Audiologist Judgement / PEDRA -5% 96% -100% -50% 0% 50% 100% False Positive Rate (Red) / Hit Rate (Blue) 2017 MFMER slide-48

49 Performance in Adults >= 50 Years 450,000 Referrals / 1,000, , , , , , , , , , ,377 No Disease Disease Miss rate 50,000-26,396 12,479 10,886 11,550 12, AAO FDA CEDRA PEDRA 2017 MFMER slide-49

50 Things that didn t work out as planned Yet! 2017 MFMER slide-50

51 Word Recognition Speech recognition scores classified by category: Excellent >90% Good >80% Fair >70% Poor <=60% Z Score Difference from AI Predication 2017 MFMER slide-51

52 Word Recognition Contribution * 100% 80% Hit Rate (%) 60% 40% 20% Validation of Mayo Asymmetry Method Lowest Word Recognition score Expected - Observed Difference in Standard Deviation Units 0% 0% 20% 40% 60% 80% 100% False Positive Rate (%) * Preliminary 2017 MFMER slide-52

53 Acoustic Reflex Thresholds 70 db 75 db 80 db 85 db 90 db 95 db 110 Deflection ( 0.5 mm/ division) Reflex Threshold in dbhl Titan Default GSI Maico kHz 1kHz 2kHz 4kHz MFMER slide-53

PEDRA Audiology can play an important role in otologic disease detection with PEDRA Position we will see more hearing impaired patients Cost we are less expensive Reason for Medicare Payment of

54 PEDRA Audiology can play an important role in otologic disease detection with PEDRA Position we will see more hearing impaired patients Cost we are less expensive Reason for Medicare Payment of option #2? Critical point: We must integrate into healthcare system Coordinate with PCP / Medical Home** Find disease and refer aggressively Team approach no profession can do it alone Option #2 Option #3 ** Proscriptive (option #3) versus collaborative (option #2) care 2017 MFMER slide-54

55 Which Model Has the Best Outcomes? Cost / diagnosis? Cost / hearing Aid? Cost / hearing benefit? Option #1 Option #2 Option #3 Option #4 Impaired Person Impaired Person Impaired Person Primary Care provider Impaired Person Primary Care provider aid Audiologist aid Audiologist Audiologist Ear, Nose & Throat Provider aid aid 2017 MFMER slide-55

56 What Should Insurance / Medicare Pay For...? 1. Prevention of hearing impairment and associated communicative disorders on a societal level 2. Detection and assessment of hearing impairment and associated communicative disorders 3. Detection and referral for treatment of diseases causing hearing impairment 4. Aural Rehabilitation 5. Prognosis: individualized future risk for hearing impairment and how to mitigate 2017 MFMER slide-56

57 What Should Insurance / Medicare Pay For...? Audiology Healthcare Practitioner / Medical Model Wellness Care Consumer / Market Model Disease Detection, Diagnosis & Progression Auditory Rehabilitation following disease Auditory Rehabilitation for Age & lifestyle hearing problems Conservation Consumer Electronics & Internet of things Product Design 2017 MFMER slide-57

58 Note Pressures on Healthcare Definition Audiology: Individualized Care Disease Related (Medical Model) devices as commodity items (Consumerism/Market Model) 2017 MFMER slide-58

59 Pressures on Healthcare Definition Audiology: Individualized Care Disease Related (Medical Model) Devices as commodity items (Consumerism/Market Model) Audiologist s Choice! 2017 MFMER slide-59

60 Thank You Mayo.edu 2017 MFMER slide-60

61 Questions & Discussion 2017 MFMER slide-61

Works Consulted 21CFR801.420 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=801.420 Accessed 9/1/2015 21CFR801.421 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=801.421 Accessed 9/1/2015 Blevins NH.

62 Works Consulted 21CFR Accessed 9/1/ CFR Accessed 9/1/2015 Blevins NH. Presbycusis. In: UpToDate, Deschler DG (Ed), UpToDate, Waltham, MA (Accessed on June 21, 2015.) Browning GG, Gatehouse SG, (1992). The prevalence of middle ear disease in the adult British population. Clinical Otolaryngology. 17(4): DOI: /j tb01004.x Dinces, EA. Meniere disease. In: UpToDate, Deschler DG (Ed), UpToDate, Waltham, MA. (Accessed on June 21, 2015.) Freeman B, (2008). A look at 2020: Will there be fewer audiologists and more patients? AudiologyOnline.com, course (Accessed on September 7, 2015.) Lin FR, Niparko JK, Ferrucci L, (2011) Loss Prevalence in the United States. Arch Intern Med. 171(20): doi: /archinternmed PMCID: PMC NIHMSID: NIHMS Monasta L, Ronfani L, Marchetti F, Montico M, Vecchi Brumatti L, et al. (2012). Burden of Disease Caused by Otitis Media: Systematic Review and Global Estimates. PLoS ONE 7(4): e doi: /journal.pone The National Institute on Deafness and Other Communication Disorders (NIDCD). (April 2015). Quick Statistics. Retrieved July 20, 2015 from U.S. Census Bureau. (July 2007). Summary File 1: 2000 Census of Population and Housing. Retrieved June , from Table 1. U.S. Census Bureau. (September 2012). Summary File 1: 2010 Census of Population and Housing. Retrieved June , from Table 1. Weber, PC. Etiology of hearing loss in adults. In: UpToDate, Deschler DG (Ed), UpToDate, Waltham, MA. (Accessed on June 21, 2015.) Zapala DA, Criter RE, Bogle JM, Lundy LB, Cevette MJ, Bauch CD. (2012). Pure-tone hearing asymmetry: a logistic approach modeling age, sex, and noise exposure history. J Am Acad Audiol. 23(7): PMID: DOI: /jaaa Zapala DA, Stamper GC, Shelfer JS, Walker DA, Karatayli-Ozgursoy S, Ozgursoy OB, Hawkins DB. (2010). Safety of audiology direct access for Medicare patients complaining of impaired hearing. J Am Acad Audiol. 21(6): PMID: DOI: /jaaa Zapala DA, Shaughnessy K, Buckingham J, Hawkins DB. (2008). The importance of audiologic red flags in patient management decisions. J Am Acad Audiol. 19(7): PMID: President s Council of Advisors on Science and Technology, Aging America & Loss: Imperative of Improved Technologies. Donahue A, Dubno JR, Beck L. Accessible and affordable hearing health care for adults with mild to moderate hearing loss. Ear Hear. 2010; 31(1):2 6. Available at Cox RM, Johnson JA, Xu J. Impact of advanced hearing aid technology on speech understanding for older listeners with mild to moderate, adult onset sensorineural hearing loss. Gerontology. 2014; 60(6): 557:568. Available at J. Johnson, J. Xu, R. Cox. Choosing hearing aid technology for older adults: Are premium features better? Talk presented at: Third Meeting of the Committee on Accessible and Affordable Healthcare for Adults; Sept 10, 2015; Washington, D.C. Available at Kirkwood DH. Research firm analyzes market share, retail activity, and prospects of major hearing aid manufacturers. News Watch; July 3, Available at firm analyzes market share retail stores prospects of major hearing aid makers/ Why COSTCO rules in hearing aids as well as gummy bears. Bloomberg Business; July 11, Available at /why costco rules in hearing aids dot as well as gummiebears. Johnson EE, Ricketts TA. Dispensing rates of four common hearing aid product features: associations with variations in practice among audiologists. Trends Amplif. 2010; 14(1): Available at Kochkin S, Beck DL, Christensen LA, et al. MarkeTrak VIII: The impact of the hearing healthcare professional on hearing aid user success. The Review. 2010; 17(4): 12, 14, 16, 18, 23, 26, 27, 28, 30, 32, & 34. Available at ConsumerReports.com. well in a noisy world. Consumer Reports magazine; July Available at archive/july 2009/health/hearing aids/overview/hearing aidsov.htm. Steven B. Adams, Who Will Hear? An Examination of the Regulation of Aids. J. Contemp. Health L. & Pol'y 1995; 11: Available at: U.S. Food and Drug Administration (FDA). Supporting Statement for Aid Devices, Professional and Patient Labeling and Conditions for Sale. 21 CFR and OMB No Silver Spring, MD: Available at Gal TJ. Shinn J, Huang G. Current epidemiology and management trends in acoustic neuroma. Otolaryngology Head Neck Surg. 2010; 142(5): Available at Carlson ML, Habermann EB, WagieAE, et al. The Changing landscape of Vestibular Schwannoma Management in the United States a Shift toward Conservatism. Otolaryngology Head Neck Surg. 2015; Jun 30. Available at Cavitt, K., Audiology Online Community Listserve, Nov 12, 2016, available at Windmill, I., Audiology Online Community Listserve, March 30, 2016, available at MFMER slide-62

63 Audiology Evaluation and Management Audiological Evaluation Audiological Rehabilitation 2017 MFMER slide-63

64 Audiology Evaluation and Management Audiological Evaluation Audiological Rehabilitation 2017 MFMER slide-64

Before beginning I want to acknowledge with gratitude, the agencies who have supported our work, particularly the NIDCD.

1 Before beginning I want to acknowledge with gratitude, the agencies who have supported our work, particularly the NIDCD. 2 The accessibility and affordability of hearing healthcare is driven by several