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TAA Webinar: Infection Control

 

COVID-19 Resource Updates

TDLR Updates

Governor Abbott Waives Regulations, Expands Telehealth Options

TAA's Response & Resource Guide to COVID-19

 

OSHA Guidance on Preparing the Workplace for COVID-19 (2020)

 

Information re: SBA Loans and Paycheck Protection Program

*TIME SENSITIVE INFORMATION*

We strongly urge all members to apply for the SBA loans under the new Paycheck Protection Program.

 

Lenders can begin processing loans at 12:01am EDT on Friday, April 3, 2020. We strongly encourage members to give urgent attention to applying for these loans, as there are limited funds available.

 

You can apply through any existing SBA 7(a) lender or through any federally insured depository institution or federally insured credit union that is participating.

 

Paycheck Protection Program Application Form

 

Paycheck Protection Information Sheet

 

Paycheck Protection Program Overview

 

OTC Hearing Aid Proposed Regulations Likely Delayed Until Q1 2020

 

Published on 

FDAThe proposed regulations for a new class of over-the-counter (OTC) hearing aids—which had previously been slated for release by the US Food and Drug Administration (FDA) this month—are now likely to be released sometime in the first quarter of 2020, according to industry sources and market analyst Niels Leth of Carnegie Research.

As previously reported in this blog, a Notice of Proposed Rulemaking (NPRM) for a “category of hearing aids to promote the availability of additional kinds of devices that address age-related hearing loss” was cited as having an action date of sometime in November (11/00/19) by the FDA. However, this Unified Agenda publishing date is widely regarded as a “target date.” According to industry sources, the document has not yet been sent to the Office of Management and Budget (OMB) and the Office of Information and Regulatory Affairs (OIRA)—which usually require at least 4-8 weeks for their review.

Given this, it’s likely the earliest the proposed regulations for OTC hearing devices will be available for public comment is January or February 2020. However, FDA has not yet made a public statement regarding the timeline.

The FDA’s deadline for the proposed OTC hearing aid rule is August 18, 2020. Because hearing aids usually take a backseat to other life-saving devices and more pressing issues within the FDA, it is not uncommon for the Agency’s timelines for hearing-related regulations to change. Srinivas “Nandu” Nandkumar, PhD, then the branch chief of the FDA’s Division of Ophthalmic and Ear, Nose, and Throat (ENT) Devices, warned about factors working against an accelerated timeline as long ago as the 2017 ADA Convention. More recently, Dr Nandkumar told Hearing Industries Association (HIA) members at the 2019 Membership Meeting that it was preferable to have a lot of time between the proposed regulations and final rule-making on the issue of OTC devices, suggesting that the proposed OTC rules might be coming sooner than anticipated.  However, as noted, hearing devices traditionally have a lower priority in comparison to other life-saving medical devices, and the FDA continues to have a backlog of issues requiring attention. There also has been a reshuffling within FDA, with Dr Nandkumar becoming director of the FDA’s Dental Devices division—although it is reported he will continue to be involved in the OTC hearing device regulations.

The OTC Hearing Aid Act of 2017 was passed by Congress and signed by President Trump on August 18, 2017. It requires the FDA to create and regulate a category of OTC hearing aids for adults with “perceived” mild-to-moderate hearing loss and to ensure the devices meet the same high standards for safety, consumer labeling, and manufacturing protection that all other medical devices must meet. The legislation requires the FDA to establish an OTC hearing aid category within 3 years of passage of the legislation, and finalize a rule within 180 days after the close of the comment period—or an August 18, 2020 deadline for the proposed rule.

NPRMs explain what the FDA intends to require or do, as well as its scientific and/or policy reasons for the decision. An NPRM also solicits comments from the public, and these are generally submitted via the Federal Government’s electronic docket site, available at Regulations.gov. FDA can also issue Advance Notice of Proposed Rulemaking (ANPRM), announced in The Federal Register, for formulating its rules.

On October 28, FDA did publish in the Federal Registry its final order regarding the De Novo application for the Bose Hearing Aid—a user-fitted hearing aid intended for mild-to-moderate hearing loss that can be adjusted via a mobile app—preparing the way for other self-fitting hearing aids for similar special controls.  However, this is not to be confused with the new OTC hearing aid classification mandated by Congress.

 

Disaster Response from Texas Governor's Office

From: Katie Brice <[email protected]>
Sent: Wednesday, October 30, 2019 10:03 AM
To: Katie Brice <[email protected]>
Subject: Disaster Response from Texas Governor's Office
Importance: High

 

I have been asked to distribute the following information from the Governor’s Office to all stakeholder groups.  Please see below:

 

On September 19,  in accordance with Sections 418.016 and 418.171 of the Texas Government Code, Governor Greg Abbott temporarily suspended all necessary statutes and rules to allow a healthcare professional licensed and in good standing in another state to practice in various facilities in Texas to assist with disaster response operations for Tropical Storm Imelda. Read more at https://gov.texas.gov/news/post/governor-abbott-declares-state-of-disaster-as-severe-weather-hits-texas.

 

The suspension allows a healthcare provider who holds a license, certificate, or other permit issued by another state jurisdiction satisfying qualifications for professional, mechanical, or other skills to render aid in this state to meet an emergency or disaster.

 

This suspension is in effect until terminated by the Office of the Governor or until the disaster declaration is lifted or expires.

 

For the healthcare provider types listed below, a healthcare facility must submit to the Texas Department of Licensing and Regulation (TDLR) by email each out-of-state provider’s name, license type, state of licensure, and license identification number to: [email protected].

 

TDLR licenses the following healthcare providers:

•Athletic Trainers

•Behavior Analysts

•Dietitians

•Dyslexia Therapists and Practitioners

•Hearing Instrument Fitters and Dispensers

•Midwives

•Orthotists and Prosthetists

•Podiatrists

•Speech-Language Pathologists and Audiologists

 

If you have questions or need assistance, please call (800) 803-9202 between 7:00 a.m. and 6:00 p.m. CDT or email [email protected].

 

 

 

Katie Brice

Senior Program Specialist

Medical and Health Professions

Regulatory Program Management

Texas Department of Licensing and Regulation

(512) 334-5526

 

Donations to the Frederick N. Martin Scholarship Fund

For those wanting to donate to the Frederick N. Martin Scholarship Fund:

 

1) Click here which will take you to the UT Giving site.

2) Leave the first drop down as is with "Communication, Moody College of"

3) Go to the second drop down and type in Frederick N. Martin Scholarship Fund - it is in alphabetical order and will pre-fill as you start typing.

 

 

 

 

We have lost a special man, an audiology pioneer - Fred Martin - July 24 1931 to November 8 2018 Rest in Peace Dr. Martin - you will be missed

Rest in Peace Dr. Martin.

 

Our father, Fred Martin, passed away on November 8, 2018 at 87.  David and Leslie Anne were with him during his final days and he was at peace and free of pain.  This is Fred’s note, written years in advance, though we are editing it slightly.  He requested that no formal funeral service be carried out, mostly because he did not want to cause any more sadness about this than necessary.  He did ask that we notify some of the people who were important to him.

Fred's first love was his family and his very special dogs that he adored, as everyone who knew him is aware.   He also loved audiology.  He was proud of his students and was always excited to hear news of their accomplishments.  He felt that his former students being smart and up-to-date on the latest scientific developments was critical but not as important as being kind to patients.

One of his former students sent him a card on his 73rd birthday and attached the following, which Fred truly enjoyed.  His friends and students may recognize some of this.

Everything I needed to know… I learned from Dr. Martin

v   Take Vitamin C

v   Proof read

v   Write thank-you letters

v   Pets save lives

v   Keep away from Q-tips

v   All you’ve got is your good name & your knowledge

v   If you write “Welcome” on your back people will wipe their feet on you

v   Macs are smarter

v   Don’t take sleep for granted

v   A yogurt a day keeps the doctor away

v   Ontogeny recapitulates phylogeny

v   Witty responses:  “I’m sorry you feel that way,” & “What would you like me to do about it?”

v   Marry your best friend

Fred preferred that you all not send gifts or flowers at his passing.  He would have much preferred that if you are moved to do something that you make a donation to your favorite charity.  His included the American Heart Association, American Cancer Society, St. Jude’s Hospital, the Scott Haug Foundation, or any of the dog rescue groups like the Austin Humane Society.  There is also a Frederick N. Martin Endowed Scholarship in Communication Sciences and Disorders at The University of Texas at Austin.

As a brief addendum, we would like to add our own thanks to all of you for the warmth and concern that you have provided Fred and all of us over the years.  The outpouring of love that we have witnessed over the past few months is testament to Fred’s love for and commitment to excellence in his work and in all his endeavors.  We are very proud of him!

 

All the Best,

David and Leslie-Anne Martin

[email protected][email protected]

 

FDA OTC HA LETTER TO INDUSTRY

Click here to download a copy of this letter.