Hearing Loss & Healthy Aging: A Public Health Perspective Frank R. Lin, M.D. Ph.D. Associate Professor of Otolaryngology, Geriatric Medicine, Mental Health, & Epidemiology Johns Hopkins University Baltimore, Maryland

Prevalence of Hearing Loss in the United States, 2001-2008 Hearing loss defined as a better-ear PTA of 0.5-4kHz tones > 25 dB Lin et al., Arch Int Med. 2011

Hearing Loss & Hearing Aid Use Prevalence in the U.S. , 1999-2006 Chien W et al, Arch Int Med, 2012

Age-Related Hearing Loss (ARHL) Basic Questions What are the consequences of ARHL for older adults? What is the impact of treating ARHL on older adults? How can ARHL be effectively addressed in the community?

Healthy Aging

Healthy Aging Hearing Loss Avoiding Injury Cognitive Vitality & Avoiding Dementia Maintaining Physical Mobility & Activity Healthy Aging Keeping Socially Engaged & Active Health Resource Utilization Hearing Loss

Hearing Loss & Healthy Aging Common Cause or Modifiable Risk Factor ? Cognitive & Physical Functioning Hearing Loss Common pathological process

“Effortful listening” Hearing Loss & Cochlear impairment Frequency Time  Intensity  Decreased sensitivity & distortion in sound encoding “Sunday” “Effortful listening”

Hearing Loss & Healthy Aging Common Cause or Modifiable Risk Factor Cognitive Load Add in brain aging, kahneman, and voxel based image Then overview with epi results Then box with RCT Myth 2 HL can be succesfully treated by any audiologist?? Then slide Then case presentation Cognitive & Physical Functioning Hearing Loss Common pathological process

Hearing Loss & Cognitive Load Kahneman model of shared attention and resource capacity (D. Kahneman, Attention & Effort,1973) Cognitive Resource Capacity Available Cognitive Resources For Performance of Tasks Age-Related Decline Auditory Perceptual Processing Requirements

Hearing Loss & Cognitive Load Poorer hearing is associated with: A. Reduced language-driven activity in primary auditory pathways B. Increased compensatory language-driven activity in pre-frontal cortical areas D: areas activated to a greater degree by elderly poor comprehenders than by elderly good comprehenders. In contrast with this area of reduced activation, subtracting the activation pattern of the poor comprehenders from that of the good comprehenders, shown in Fig. 3D, revealed the poor comprehenders to be upregulating dorsolateral prefrontal cortex to a degree not shown by the good comprehenders. Dorsolateral prefrontal cortex is often activated during general problem-solving activities, regardless of the verbal or nonverbal nature of the material (Paulus et al. 2001; Prabhakaran et al. 2001; Ramnani and Owen 2004). This prefrontal region is not activated in young adults during sentence-comprehension tasks. This would suggest that the older adults who are less successful in their comprehension of grammatically complex sentences were attempting to understand these sentences by adopting a general- purpose problem-solving approach to the task. Peelle et al, J. Neurosci, 2011 B Grossman et al, Brain Lang, 2002

Hearing Loss & Healthy Aging Common Cause or Modifiable Risk Factor Cognitive Load Cognitive & Physical Functioning Hearing Loss Brain structure/function Common pathological process

Double Hit Theoretical Model Hearing Loss & Brain Structure/Function Microvascular Disease Alzheimer’s Neuropathology 1021 Structure/ Function Hearing Impairment F. Lin & M. Albert, Aging & Mental Health, 2014

Hearing Loss & Healthy Aging Common Cause or Modifiable Risk Factor Cognitive Load Cognitive & Physical Functioning Hearing Loss Brain structure/function Social Isolation Common pathological process

Health Behavioral Pathways Psychological Pathways Cognitive & Physical Functioning Social Isolation Health Behavioral Pathways Smoking Adherence to medical tx Diet Exercise Psychological Pathways Self-esteem Self-efficacy Coping Sense of well-being Physiologic Pathways HPA axis response Immune system fxn Cardiovascular reactivity Social isolation is associated with upregulation of pro-inflammatory genes & increased inflammation Cole & Cacioppo, Genome Biology, 2007 Cole & Cacioppo, PNAS, 2011

Hearing Loss & Healthy Aging Common Cause or Modifiable Risk Factor Cognitive Load Cognitive & Physical Functioning Hearing Loss Brain structure/function Social Isolation Common pathological process

Hearing Loss & Healthy Aging Datasets for Epidemiologic Analyses NHANES: National Health and Nutritional Examination Surveys Cross-sectional, representative sample of U.S. population BLSA: Baltimore Longitudinal Study of Aging Ongoing prospective study of older adults since 1958 HealthABC: Health, Aging, & Body Composition Study Prospective, population-based study of ~3000 adults 70 years and older

Healthy Aging Hearing Loss Avoiding Injury Cognitive Vitality & Avoiding Dementia Maintaining Physical Mobility & Activity Healthy Aging Keeping Socially Engaged & Active Health Resource Utilization Hearing Loss

Projected Worldwide Prevalence of Dementia 2010-2050 Alzheimer’s Disease International, 2009

Hearing Loss & Cognition Background Memory Free and cued selective reminding test (FCSRT) Executive Function Trail Making B Stroop Mixed Digit symbol substitution Psychomotor/processing speed Verbal function & language These tests are not dependent on hearing.

Hearing Loss & Cognition Executive Function: Trail Making B 8 7 6 5 1 4 3 2 C E B Trail Making B H F G D A

Hearing Loss & Cognition Executive Function: Stroop Mixed GREEN RED BLUE RED YELLOW BLUE GREEN BLACK Stroop Mixed

DSS: Digit Symbol Substitution Test Hearing Loss & Cognition Executive Function: Digit Symbol Substitution Test (DSS) DSS: Digit Symbol Substitution Test

Hearing Loss and Cognition Cross-Sectional Studies NHANES N = 605 adults 60-69 years Lin, J. Geront. Med. Sci., 2011 BLSA N = 347 adults >60 years Lin et al., Neuropsych., 2011 Models adjusted for age, sex, race, education, diabetes, smoking, hypertension

Hearing Loss & Cognitive Decline HealthABC Adjusted DSS scores by years of follow-up and hearing loss status in 1,966 adults > 70 years followed for 6 years 32% faster rate of cognitive decline in DSS scores in HL vs. NH Adjusted for age, sex, race, education, study site, smoking status, hypertension, diabetes, and stroke history Lin et al. JAMA Int Med. 2013

Risk of incident all-cause dementia (compared to normal hearing)a Hearing Loss & Incident Dementia Dementia incidence in 639 adults followed for >10 years in the BLSA Risk of incident all-cause dementia (compared to normal hearing)a HR 95% CI p Mild 1.89 1.00 – 3.58 0.05 Moderate 3.00 1.43 – 6.30 .004 Severe 4.94 1.09 – 22.4 .04 a Adjusted for age, sex, race, education, DM, smoking, & hypertension Lin et al., Arch Neuro., 2011

Hearing Loss & Incident Dementia Dementia Incidence in 1057 Men Followed for 17 years in the Caerphilly Prospective Study (U.K.) J. Gallacher et al., Neurology, 2012

Healthy Aging Avoiding Injury Avoiding Injury Cognitive Vitality & Avoiding Dementia Maintaining Physical Mobility & Activity Maintaining Physical Mobility & Activity Healthy Aging Keeping Socially Engaged & Active Keeping Socially Engaged & Active Health Resource Utilization/Mortality Health Resource Utilization/Mortality Cognition/Dementia/Brain Aging J Gerontol A Biol Sci Med Sci. 2016 Apr 12. Am J Epidemiol. 2015 May 1;181(9):680-90. Aging Ment Health. 2014;18(6):671-3. Neuroimage. 2014 Apr 15;90:84-92. JAMA Intern Med. 2013 Feb 25;173(4):293-9. Neuropsychology. 2011 Nov;25(6):763-70. Gerontol A Biol Sci Med Sci. 2011 Oct;66(10):1131-6. Arch Neurol. 2011 Feb;68(2):214-20. Injury/Physical Functioning J Aging Health. 2016 Aug;28(5):890-910. J Aging Health. 2016 Jun;28(4):644-60. J Am Geriatr Soc. 2016 Apr;64(4):906-8. J Gerontol A Biol Sci Med Sci. 2015 May;70(5):654-61. J Am Geriatr Soc. 2014 Aug;62(8):1427-33. J Am Geriatr Soc. 2014 Jun;62(6):1186-8. Am Geriatr Soc. 2014 May;62(5):850-6. Gait Posture. 2013 May;38(1):25-9. Health Economics/Mortality J Aging Health. 2016 Feb;28(1):68-94. JAMA Otolaryn Head Neck Surg. 2015 Oct;141(10):944-6. J Am Geriatr Soc. 2015 Jun;63(6):1146-52. J Gerontol A Biol Sci Med Sci. 2015 Jan;70(1):85-90. J Am Geriatr Soc. 2014 Nov;62(11):2207-9. J Am Geriatr Soc. 2014 Jun;62(6):1188-9. JAMA. 2013 Jun 12;309(22):2322-4. Social Engagement/Mental Health J Aging Health. 2016 Sep;28(6):979-94. J Gerontol B Psychol Sci Soc Sci. 2016 May;71(3):400-4. J Aging Health. 2016 Feb 24. Otolaryngol Head Neck Surg. 2014 Mar;150(3):378-84. J Am Geriatr Soc. 2013 Sep;61(9):1627-9.

Hearing Loss & Healthy Aging Common Cause or Modifiable Risk Factor Cognitive Load Add in brain aging, kahneman, and voxel based image Then overview with epi results Then box with RCT Myth 2 HL can be succesfully treated by any audiologist?? Then slide Then case presentation Cognitive & Physical Functioning Hearing Loss Brain structure/function Social Isolation Common pathological process

Age-Related Hearing Loss (ARHL) Basic Questions What are the consequences of ARHL for older adults? What is the impact of treating ARHL on older adults? How can ARHL be effectively addressed in the community?

The question of whether treating hearing loss could delay cognitive/physical decline or dementia remains unknown There has never been a randomized controlled trial of treating hearing loss to explore effects on reducing the risk of cognitive decline/dementia

Hearing Loss & Cognition Mechanistic Pathways Intervention Cognitive Load Changes in brain structure Reduced Social Engagement Cognitive Functioning Hearing Loss Hearing loss intervention could: Reduce the cognitive load of processing degraded sound Provide increased brain stimulation Improve social engagement Role of HL as a potentially modifiable, late-life risk factor for cognitive decline & dementia

Conceptual Model for the Aging, Cognition, and Hearing Evaluation in Elders (ACHIEVE) RCT In collaboration with J. Coresh, M. Albert, N. Glynn, T. Chisolm, ARIC Study Team (T. Mosley, K. Bangdiwala, K. Hayden, J. Pankow) Non-pharmacologic cognitive training intervention Proximal/Mediating Outcomes Proximal/Mediating Outcomes Primary Outcome Primary Outcome Secondary Outcomes Secondary Outcomes Intervention Intervention HRQL Social/Leisure Activities Daily Functioning Mobility Brain structure (MRI) Audibility of speech & environmental sounds Best-Practices Hearing Rehabilitative Treatment Vs. Successful Aging Control Cognitive Functioning Enhanced Verbal Communication & Social Engagement NIA R34AG064548

The ACHIEVE RCT will be Nested within the ARIC Neurocognitive Study Operational Efficiency & Scientific Power Atherosclerosis Risk in Communities (ARIC) 1987-present; n=15,792 Supported by National Institutes of Health NHLBI with ancillary studies by NCI, NEI, NIA, NIAAA, NIDCD, NIDDK, NIEHS, NINDS, NCRR & NIH Roadmap

ACHIEVE Trial Design Timeline & Overview of RCT 2014-2016 RCT planning process (R34AG046548) - Pilot study, development of protocol/operations manual, etc. 2016 $16M grant for full trial under review 2017-18 Recruitment at field sites 2018-21 Follow-up Participants: ~850 70-84 y.o., healthy, cognitively normal community-dwelling adults with untreated mild-moderate HL Intervention: Randomization to best-practices hearing rehabilitative treatment vs. successful aging intervention control Outcome: Study powered to detect 0.3 effect-size difference in rates of cognitive decline between the two groups at 3 years post-randomization NIA R34AG064548

Age-Related Hearing Loss (ARHL) Basic Questions What are the consequences of ARHL for older adults? What is the impact of treating ARHL on older adults? How can ARHL be effectively addressed in the community?

Hearing Loss & Hearing Aid Use Prevalence in the U.S. , 1999-2006 Arch Int Med, 2012

Barriers to Hearing Health Care (HHC) Cost/Affordability Access to Services &Technology

Current (only) gold-standard model of hearing care: Access to Services &Technology Current (only) gold-standard model of hearing care: Repeat clinic-based visits with audiologist/dispenser for evaluation, counseling, fitting of amplification Federal & State regulations restrict direct access to hearing aids For politzer—use slide in back

Barriers to Hearing Health Care (HHC) Cost/Affordability Awareness & Understanding Access to Services &Technology Technology Design & Utility

How can ARHL be effectively addressed in the community How can ARHL be effectively addressed in the community? Current & Future Trends Understanding & approaching hearing loss in the context of healthy aging/public health  National Academies of Science, Engineering, & Medicine (NASEM) Workshop on hearing loss & healthy aging - 2014  White House Conference on Aging & President’s Council of Advisors on Science & Technology – 2015  NASEM Hearing Loss Consensus Study– 2015 - 2016   2016-17 Food & Drug Administration re-regulation of hearing aids, Federal Trade Commission workshop, Congressional bill for OTC hearing aids Innovations in hearing health care/technology Affordable technology & Accessible services

“Are you telling me that I’m going to develop dementia?” What are the consequences of hearing loss for older adults? What is the impact of treating hearing loss on older adults? How can hearing loss be effectively addressed in the community? Hypertension  Heart attack & stroke Intervention: Medication, Lifestyle modification Hearing loss  Cognitive decline, dementia, poorer physical functioning Intervention: Comprehensive hearing tx?

Acknowledgments Johns Hopkins Jennifer Deal Joe Coresh Carrie Nieman Marilyn Albert Jon Suen Sara Mamo Nick Reed Josh Betz NIA Luigi Ferrucci Susan Resnick Yang An Eleanor Simonsick ARIC Study Team R34AG046548 R01HL096812 R33DC015062 P30AG048773 Triological Society & American College of Surgeons Clinician Scientist Award Eleanor Schwartz Charitable Foundation NIA Intramural Research Program

Innovations in Hearing Health Care Affordable Amplification Options are Needed Hearing Aids: Regulated as medical devices by the FDA $800 to $3000 per device Minimal insurance benefit (no Medicare benefit) Accepted gold standard of care Personal Sound Amplification Products (PSAPs): Unregulated by the FDA Cost $30-300 per device E-commerce Tremendous recent advances paralleling consumer electronics industry For politzer—use slide in back

Mean AZ Bio Scores Across Conditions Results (N = 33) Nick Reed Nick Reed Mean AZ Bio Scores Across Conditions +5 dB SNR

Innovations in Hearing Health Care Affordable & Accessible “Stepping Stones” are Needed for Hearing Health Care Technology – Personal sound amplifiers (PSAP) Over-the-counter “hearing aids” with in-situ testing & verification Cost < $100-300 Services - Community health care workers Community-based hearing screening Counseling, education, & provision of sound amplifiers & other assistive technologies Referral as needed For politzer—use slide in back

Access HEARS: Hearing care Equality through Accessible Research & Solutions BaltimoreHEARS Low-income minority older adults inner city Baltimore HEARS Intervention 1) Hearing Loss Screening 2) Device Orientation: - Self-fit amplification device - Individual programming 3) Counseling: - Expectation management - Communication Strategies Pilot Studies in Multiple Populations Carrie Nieman Insert graphic Older Adults with Cognitive Impairment or Dementia Sara Mamo Korean-American Older Adults – Korean Martyrs Catholic Church Carrie Nieman Janet Choi Definitive Trials Licensing & Dissemination Non-profits Local government Pilot Studies Multiple Communities Outcomes in participant & communication partner Social Engagement Communication Activities HRQL Intervention Development 2016-2019 2014-2016 2013

Carrie Nieman

Carrie Nieman $200

Baltimore HEARS Pilot (n = 15) Change in Hearing Handicap Inventory Carrie Nieman Mean change = - 9.5 Effect Size = -0.96 Hearing aids = -8 to -16 None Mild Moderate Significant HHIE - Baseline

Scores after HEARS Intervention Memory Clinic HEARS Project Results (N = 20) of Neuropsychiatric Inventory Scores after HEARS Intervention Sara Mamo September 17, 2018

Memory Clinic HEARS Project Feedback – Son-in-law of a 91 yo woman with MMSE of 17 Sara Mamo

How can ARHL be effectively addressed in the community? Future Trends Understanding & approaching hearing loss in the context of healthy aging  National initiatives now from White House PCAST, NASEM, FDA, FTC, Congress Innovations in hearing health care/technology Accessible services & affordable technology Third-party reimbursement of hearing health care Unbundling of hearing health care Coverage for audiologic rehabilitative services (not devices)

Hearing Loss & Accelerated Brain Volume Decline BLSA Hypothesis: Hearing loss is associated with accelerated atrophy in the superior, middle, and inferior temporal gyri 126 participants (56-86 yrs) in the neuroimaging substudy of the BLSA Mean follow-up duration of 6.4 years 1.5T MRI performed annually

Faster decline in brain volume in HL vs. NH Region of Interest & Voxel-Based Analyses HL is associated with accelerated atrophy over Right superior, middle, & inferior temporal gyri L Faster decline in brain volume in HL vs. NH Lin et al., Neuroimage 2014

Double Hit Theoretical Model Hearing Loss & Brain Structure/Function Microvascular Disease Alzheimer’s Neuropathology 1021 Structure/ Function Hearing Impairment F. Lin & M. Albert, Aging & Mental Health, 2014