managing disease risk in hearing healthcare delivery€¦ · managing disease risk in hearing...

©2015 MFMER | slide-1

Managing Disease Risk in Hearing Healthcare Delivery

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, Au.D., Ph.D., Research Fellow, Mayo Clinic in Arizona


Acknowledgements • NIDCD grant R21-R33 DC013115-02

Accessible and Affordable Hearing Health Care • The Knowles Hearing 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 Hearing Healthcare


Managing Disease Risk: An Evolving Challenge in Hearing Healthcare


The Baby Boomer Bump – 2000 Census

0

5,000,000

10,000,000

15,000,000

20,000,000

25,000,000

0 20 40 60 80 100 120

U.S

. Pop

ulat

ion

Age in Years

2000

Baby Boomer Bump


The Baby Boomer Bump – 2010 Census

0

5,000,000

10,000,000

15,000,000

20,000,000

25,000,000

0 20 40 60 80 100 120

U.S

. Pop

ulat

ion

Age in Years

2000 2010

Baby Boomer Bump


The Baby Boomer Bump – 2015 Projection

0

5,000,000

10,000,000

15,000,000

20,000,000

25,000,000

0 20 40 60 80 100 120

U.S

. Pop

ulat

ion

Age in Years

2000

2010

2015 Projection


What Does This Mean for Me? • Prevalence of Communicatively Significant

Hearing Loss in 2010: •  1 in 5 60-70 year olds (6,000,000) •  1 in 2 70 – 80 year olds (8,500,000) •  3 in 4 80+ year olds (8,900,000)

• Served by •  1300 ENTs •  1300 Audiologists •  600 Neurotologists / Otologists •  900 Hearing Instrument Dispensers

©2012 MFMER |

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In Theory… •  In 2010 each professional would need to see

900 new patients to meet demand • 2015 we would need to see 1103 new patients

to meet demand • Would it not be nice if each of us sold 2200

hearing aids / year??? $$$

©2012 MFMER |

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But We Don’t… • Less than 1 in 5 hearing impaired individuals

purchase hearing aids • Most wait 5-10 years before purchasing

• Cost / benefit • Alternatives

•  Internet • ALDs • PSAPs

©2012 MFMER |

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Direct to Consumer Devices • Technology can solve problems of mild to

moderate hearing loss?

• Consumer Electronics Industry versus the Hearing Aid Industry

• Audiology fits where?

©2012 MFMER |

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What Are the Rolls of ENT and Audiology? • ENT:

• Disease prevalence will increase with population

•  Implantable devices will increase • Audiology:

• Greater demand for hearing aids that work! • Part of the solution – but the whole

solution? • OTC Hearing aids for mild to moderate

hearing loss? ©2012

MFMER | slide-12


Ear Disease and Hearing Loss

0

2,000,000

4,000,000

6,000,000

8,000,000

10,000,000

12,000,000

14,000,000

20–29 30–39 40–49 50–59 60–69 70–79 80+

Popu

latio

n Pr

ojec

tions

- 20

10

Age in Years

All Hearing Loss

Based on projected population percentages calculated by Lin et al. 2011



0

2,000,000

4,000,000

6,000,000

8,000,000

10,000,000

12,000,000

14,000,000

20–29 30–39 40–49 50–59 60–69 70–79 80+

Popu

latio

n Pr

ojec

tions

- 20

10

Age in Years

All Hearing Loss

All Ear Disease



-

10,000,000

20,000,000

30,000,000

40,000,000

50,000,000

60,000,000

70,000,000

80,000,000

2000 2010 2015

Hea

ring

Impa

ired

Popu

latio

n ≥

50 Y

rs.

Hearing Loss

Ear Disease + 25%

+ 102%

Today, ear disease is encountered less frequently in hearing aid seeking adults.


FDA Preferred Model for Ear Disease Surveillance

ENT

Audiology / Hearing

Test

ENT

Audiology / Hearing

Aids

ENT Treatment

Disease? 4 - 12%

Benign > 88%

100% 100%

100%

Adults seeking relief from hearing loss…

What is the cost of using this model? Time, Money, Accessibility?


FDA Preferred Model for Ear Disease Surveillance

ENT

Audiology / Hearing

Test

ENT

Audiology / Hearing

Aids

ENT Treatment

Disease? 4 - 12%

Benign > 88%

100% 100%

100%


What is the cost of using this model? Time, Money, Accessibility?


FDA Waiver Model for Ear Disease Surveillance

Audiologist / HIS ENT

Hearing Aids

Red Flag Criteria Disease?

Benign?? ?? %



Can Audiologists Assess Ear Disease Risk?

Audiologist Evaluation

Hearing Aids / Communication Management

Red Flag or Other Risk Indicator

Benign


Independent Assessment by Audiologists,

Otolaryngology & Neurotology Physicians

Zapala, et al. (2010)


FDA Waiver Model for Ear Disease Surveillance

Audiologist / HIS ENT

Hearing Aids

Red Flag Criteria Disease?

Benign?? ?? %


VA Experience: Only 1.7% of Individuals over the age of 50 years had disease

needing ENT Management


Standardizing Ear Disease Risk Assessment

for Audiologists

The creation of PEDRA


Professional Ear Disease Risk Analytics (PEDRA)

Real-Time Estimate of Ear Disease Risk

Algorithmic Disease Detection Analytics

Simple Standardized Physical Examination

Structured Interview


First Job For Audiology

•  Identify ear disease accurately and refer

• Evidence is growing that we do as good as Neurotolgy in this area


Consumer

Hearing Aids

PSAPs

Hearable

Consumers Seek Affordable, Accessible Solutions to Hearing Loss

Direct to Consumer Sales


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


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

•  71% of age related hearing loss cases accurately identified

0

0.2

0.4

0.6

0.8

1

0 0.2 0.4 0.6 0.8 1 Se

nsiti

vity

1 - Specificity


Summary •  The FDA preferred method:

•  From a systems approach - produces a bottleneck and must change

•  Audiology based disease detection and referral is a necessity

•  We have to plan for consumers access to OTC hearing devices

•  Disease detection

•  Communication improvement


Future of Audiology: Evolve or Die

• There is a strong societal need and growing demand for Audiology

• There are profound changes coming down the road

• We need to carefully retool for the next several decades:

• We need to focus on services of value

©2012 MFMER |

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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. 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):317-21. DOI: 10.1111/j.

1365-2273.1992.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 12270. (Accessed on September 7, 2015.)

•  Lin FR, Niparko JK, Ferrucci L, (2011) Hearing Loss Prevalence in the United States. Arch Intern Med. 171(20): 1851–1852. doi: 10.1001/archinternmed.2011.506PMCID: PMC3564588NIHMSID: NIHMS424132

•  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): e36226. doi:10.1371/journal.pone.0036226 •  The National Institute on Deafness and Other Communication Disorders (NIDCD). (April 2015). Quick Statistics. Retrieved July 20, 2015 from

http://www.nidcd.nih.gov/health/statistics/pages/quick.aspx

•  U.S. Census Bureau. (July 2007). Summary File 1: 2000 Census of Population and Housing. Retrieved June 21 2015, from Table 1. http://www.census.gov/prod/cen2010/briefs/c2010br-03.pdf

•  U.S. Census Bureau. (September 2012). Summary File 1: 2010 Census of Population and Housing. Retrieved June 21 2015, from Table 1.

http://www.census.gov/prod/cen2010/briefs/c2010br-03.pdf •  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):553-70. PMID:22992262. DOI:10.3766/jaaa.23.7.8. •  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):365-79. PMID:20701834. DOI:10.3766/jaaa.21.6.2. •  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):

564-70. PMID:19248733.

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