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Time (Eastern) Topic Name of Session Chair / Speakers 8:30 am - 8:35 am Day 2: Welcome & Recap Tieuvi Nguyen, PhD Food and Drug Administration 8:35 am - 9:45 am SESSION 4: Evaluation of Bioelectronic Implants: Safety 8:35 am - 9:05 am Bioelectronic Implants: Overview of Clinical Safety Endpoints and Evidence James Weiland, PhD University of Michigan 9:05 am - 9:45 am Moderated Q&A: Safety of Bioelectronic Implants Moderator: Michael Repka, MD, MBA Johns Hopkins University Panelists: Gislin Dagnelie, PhD, Johns Hopkins University Mark Humayun, MD, PhD, University of Southern California Institute for Biomedical Therapeutics Raymond Iezzi, MD, Mayo Clinic Robert MacLaren, MB ChB DPhil FRCOphth FRCS FACS FMedSci, University of Oxford Joseph Martel, MD, University of Pittsburgh José-Alain Sahel, MD, University of Pittsburgh Philip Troyk, PhD, Illinois Institute of Technology James Weiland, PhD, University of Michigan 9:45 am - 9:55 am Break 9:55 am - 11:35 am SESSION 5: Clinical Outcome Assessments and Patient Preference 9:55 am - 10:20 am FDA Regulatory framework for Clinical Outcomes Assessments and Patient Preference Fraser Bocell, PhD Food and Drug Administration David Gebben, PhD Food and Drug Administration 10:20 am - 10:40 am Clinical Outcomes Assessment for Bioelectronic Implants: NEI Perspective Emily Chew, MD National Eye Institute 10:40 am - 11:10 am Clinical Outcomes Assessment and Performance-Based Testing for Bioelectronic Implants: University of Pittsburgh Emily Grattan, PhD, OTR/L University of Pittsburgh Rakie Cham, PhD University of Pittsburgh Jose Sahel, MD University of Pittsburgh 11:10 am - 11:15 am Patient Experiences 11:15 am - 11:35 am Moderated Q&A: Clinical Outcomes Assessment for Bioelectronic Implants Moderator: Michelle Tarver, MD, PhD Food and Drug Administration Panelists: Fraser Bocell, PhD Food and Drug Administration Emily Chew, MD National Eye Institute Todd Durham, PhD Foundation Fighting Blindness Emily Grattan, PhD, OTR/L University of Pittsburgh David Gebben, PhD Food and Drug Administration John McInerney, MS Blind and Vision Rehabilitation Services of Pittsburgh 11:35 am - 12:20 pm Break 12:20 pm - 1:30 pm SESSION 6: Effectiveness 12:20 pm - 12:50 pm Bioelectronic Implants: Overview of Clinical Effectiveness Endpoints and Evidence Gislin Dagnelie, PhD Johns Hopkins University 12:50 pm - 1:30 pm Moderated Q&A: Effectiveness of Bioelectronic Implants Moderator: Elvin Ng Food and Drug Administration Panelists: Jessy Dorn, PhD Ceribell, Inc. Shelley Fried, PhD Harvard Medical School Yannick LeMer, MD Hôpital Fondation Adolphe de Rothschild Sandra Montezuma, MD University of Minnesota Mahi Muqit, MBChB BSc (Hons) FRCOphth PhD Moorfields Eye Hospital Joseph F. Rizzo III, MD Harvard Medical School Philip Troyk, PhD Illinois Institute of Technology Daniel Yoshor, MD University of Pennsylvania 1:30 pm - 2:30 pm SESSION 7: Post-market Considerations 1:30 pm - 1:50 pm FDA: Post-Approval Studies, Postmarket Surveillance and Real World Evidence Nilsa Loyo-Berrios, PhD Food and Drug Administration 1:50 pm - 2:00 pm Patient Experiences 2:00 pm - 2:30 pm Moderated Q&A: Post-Market Considerations Moderator: Michael Repka, MD, MBA Johns Hopkins University Panelists: Patient Representatives Megan Collins, MD Johns Hopkins University Lloyd Diamond, CEO Pixium Vision Nilsa Loyo-Berrios, PhD Food and Drug Administration Flora Lum, MD American Academy of Ophthalmology Elicia M Pillion, Au.D Walter Reed National Military Medical Center Arup Roy, PhD Zikron, Inc. Eberhart Zrenner, MD University of Tuebingen 2:30 pm - 3:40 pm SESSION 8: Government Agency Opportunities for Device Innovation 2:30 pm - 3:10 pm Government Agency Programs for Bioelectronic Implants Sohi Rastegar, PhD National Science Foundation Paek Lee, PhD National Eye Institute Lina Kubli, PhD Department of Veterans Affairs Tian Wang, PhD Congressionally Directed Medical Research Programs Joeanna Arthur, PhD Defense Advanced Research Projects Agency Elvin Ng Food and Drug Administration 3:10 pm - 3:40 pm Moderated Q&A: Government Agency Opportunities for Device Innovation Co-moderators: Mark Humayun, MD, PhD University of Southern California Institute for Biomedical Therapeutics Jose Sahel, MD University of Pittsburgh Panelists: Malvina Eydelman, MD Food and Drug Administration Tony Gover, PhD National Eye Institute Lina Kubli, PhD, Department of Veterans Affairs Sohi Rastegar, PhD National Science Foundation Tian Wang, PhD Congressionally Directed Medical Research Programs Joeanna Arthur, PhD Defense Advanced Research Projects Agency 3:40 pm - 3:45 pm Day 2: Workshop Concluding Remarks and Next Steps Jose Sahel, MD University of Pittsburgh Malvina Eydelman, MD Food and Drug Administration

Time (Eastern)Topic Name of Session Chair / Speakers 8:30 am - 8:45 amDay 1: Welcome and Introduction Malvina Eydelman, MD Food and Drug Administration 8:45 am - 10:15 am SESSION 1: Bioelectronic Implants and Public Health Impact 8:45 am - 9:05 am Why do we need Bioelectronic Implants? José-Alain Sahel, MD University of Pittsburgh 9:05 am - 9:25 am Psychological Considerations Thiran Jayasundera, MD University of Michigan 9:25 am - 9:45 am Socioeconomic Considerations Nabin Paudel, PhD Retina International 9:45 am - 10:05 am Ethical Considerations Joseph Fins, MD Weill Cornell Medicine 10:05 am - 10:15 am Patient Experiences 10:15 am - 10:25 am Break 10:25 am - 12:15 pm SESSION 2: Technology and Regulation 10:25 am - 10:45 am Subretinal Implants Daniel Palanker, PhD Stanford University 10:45 am - 11:05 am Epiretinal Implants Mark Humayun, MD, PhD University of Southern California Institute for Biomedical Therapeutics 11:05 am - 11:25 am Cortical Implants Nader Pouratian, MD, PhD UT Southwestern Medical Center 11:25 am - 11:35 am Patient Experiences11:35 am - 12:15 pm Regulatory Background & Requirements Michelle Gabriele Sandrian, PhD Food and Drug Administration Lan Yue, PhD Food and Drug Administration 12:15 pm - 1:15 pm Break 1:15 pm - 2:40 pm SESSION 3: Patient Perspectives 1:15 pm - 1:40 pm Patient Panel Introductions 1:40 pm - 2:40 pm Moderated Patient Panel Discussion Moderator: Eva Rorer, MD Food and Drug Administration 2:40 pm - 2:50 pm Day 1: Wrap-Up Tieuvi Nguyen, PhD Food and Drug Administration

We introduced BARD in this week's episode of Blind Sanity. (S02E11) Here are the links to get things started. Library Of Congress website: www.loc.gov BARD website: https://nlsbard.loc.gov/nlsbardprod/support/applicationinstructions This last link allows you to register. Let us know if you need help in the comments section below. The BARD app can be found on Apple App Store and Google Play Store. It is a free app to download. There is a secured link on NLSBard website. FYI... NLS is the acronym for The National Library Service

October is Blindness Awareness month! The Perkins School for the Blind addressed four main types of blindness. Two are prevalent within children: CVI and ROP. CVI (Cortical/Cerebral Visual Impairment) is a mechanical issue of the brain in which images are distorted. ROP (Retinopathy of Prematurity) involves abnormal growth of the blood vessels in the retina, the back of the eye. The two others are Macular Degeneration and RP. Macular Degeneration is a type of deterioration of the macula, which can cause blurriness in central vision and in later stages may result in seeing straight or wavy lines. RP (Retinitis Pigmentosa) involves deterioration of the retina and causes a rare, mostly hereditary, form of tunnel vision. Throughout Blindness awareness month, our goal is to educate others about blindness and how to be an advocate for others and yourself! Click here for the Perkin’s article

This is the link discussing breast cancer and self-diagnosis for blind women. Source: https://www.accessiblepharmacy.com/breast-cancer-information-for-blind-women/

This is the link mentioned in S02E10, regarding accessibility features on Apple products. Article: Apple's Big iPhone Accessibility Focus Is a Larger Deal Than You Realize

A little late, but here we go. Click here for the Diabetes and Blindness new article. Source: https://medicalxpress.com/news/2022-09-uncovering-key-contributes-vision-loss.html Click here for link related to non-native plants causing blindness. Source: https://www.fox13now.com/news/local-news/utah-county-boy-recovering-from-reaction-to-invasive-plant

This week : -News : Non native plant causes blindness -News : Blindness and Diabetes -Deep dive of the week : 15 minutes multi topics including how your county office can help you with transportation. Click here to listen or head over to our podcast page. Source: https://www.blindsanity.com/podcast-1/episode/1f5495dc/s02e09-15-minute-all-you-can-eat-multi-topics

Tired of not being able to use Amazon like everyone else ? You are not alone ! A trillion dollar company should be able to figure this out ... Or maybe it needs some help ? These are 5 easy ways to improve Amazon experience for people with sight disability. DARK MODE ! DAMNIT ! It isn't hard , Amazon, you did it with the Alexa app ! Give us a dark mode ! Make each product picture descriptive using VoiceOver or TalkBack. You could even include product info like dimensions, warranty or even price ranges. That way we won't have to go through tons of crap ! Nowadays each product page is a mile long ! A basic description of the product as a descriptive picture would allow us to easily decide if the product is worth reading more about it or move to another one. Cut the crap. Create a dumb down version of each page so that we can get the important info right away. Allow sorting reviews from disabled people first. We have unique needs and allowing reviews from blind or low vision customers will be more helpful to us than others. Make Alexa smarter while using the app. She is pretty smart but she could learn a trick or two about accessibility and be very helpful navigating the marketplace. Part of the reason why it is so expensive to be blind is that we are not allowed basic choices and capabilities offered to regular people. Improving the marketplace will go a long way leveling the field .

Use this link to view more about the campaign known as "Iris for the World" and see how NFTs can be used to raise funds to cure blindness around the world. Source: https://finance.yahoo.com/news/fundaci-n-ojos-del-mundo-152900221.html?guccounter=1&guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAAKcZalTf2tyOVnnK-ODOZJ5hGT1sHn1-cj82LbdVYh3RF6rrRQleWIFrznPanyIBtJekVgzK6dHO5zkX8MyksI4fdsOTdpenpugOKX0erv_Y9lGNQJ5tCQtsuXl0I-4cjNChyuV7gqGtzkcnOAZB5wLQuVd0LJcTtdfYw7AIyL5P

This week: -News: Eyes for World / Iris for World, or how Blockchain can help raising funds to fight blindness around the world. -Deep Dive of the Week: Part 11 of our mobility training diary, where we learn how to cross a very busy intersection with a White Cane, relying only on the sound of traffic. Click here to listen or visit our Podcast page! Source: https://www.blindsanity.com/podcast-1/episode/1c57311f/s02e08-iris-for-the-world-mobility-training-pt-11

Until now, pressing on your phone side button to Lock Screen would stop the phone call you would be in. Convenient for some of us but for some others., like me, it isn't great. Never accidentally pressed a button with your face during a phone call ? Well we got you covered here. Go to Settings 2 fingers swap down to reveal search bar Type 'Lock Screen' and search Click on 'Prevent Lock to End Call' Scroll down and look for that option and activate it. If you want to return to the original setting proceed the same way and switch the option off.