October 2018 Connection

Save the Date: Legislative Day

​KSHA's Annual Legislative Day will take place at the State Capitol January 30th, 2019. Block your schedule and plan to join us for this engaging event that really DOES make a difference in your profession!

Leadership

EXECUTIVE BOARD

ALLISON GATEWOOD, MA, CCC-SLP
President
(W) 316-204-7093

agatewood@tps501.org

JULIE GATTS, MA, CCC-SLP
President-Elect
785-295-8045

jgatts@ku.edu

DENA HALL, AuD, CCC-A
Past President
(W) 316-634-3423

Dena.Hall@ascension.org

 

MEREDITH HAROLD, PhD, CCC-SLP
VP for SLP
(W) 785-550-6042

meredithharold@gmail.com

ROCHELLE HARDEN, AuD, CCC-A
VP for Audiology
(H) 620-491-3441

hardenrochelle@yahoo.com

ALLISON WINTERS, MEd, CCC-SLP
VP for Professional Practices
(W) 913-777-4757

allisonwinters@speechabilityllc.com

 

AMY HOCKER, MS, CFY
VP for Communications
913-787-5774

Amymhocker@gmail.com

TAMMY GONZALES, AuD, CCC-A
VP for Finance
(W) 785-233-0500

tammy.gonzales@topekaent.com

 

ELIZABETH LEATHERMAN
Student Representative

eleatherman@ku.edu


Legislative Liaisons

KRIS PEDERSEN
SLP Liaison

kpedersen@ku.edu

SAM BITTEL
Audiology Liaison

sam.bittel@gmail.com


ASHA LIAISONS

State Advocate for Medicare Policy (StAMP)-
Julie Gatts, MA, CCC-SLP

State Education Advocacy Liaisons (SEALs) 
Caryn Gustin, MS, CCC-SLP
Jasmine Steel, MA, CCC-SLP
Michelle Dinges, MA, CCC-SLP

State Advocates for Reimbursement (STARS)
Julie Stover, MS, CCC-SLP


ASHA Advisory Council Members

(Elected for three-year terms: 2013-2016/2012-2015)

SLP Advisory Council
Jane Wegner, PhD, CCC-SLP Elected 2013
(W) 785-864-4690

jwegner@ku.edu

Audiology Advisory Council
C. Frederick Britten, PhD, CCC-A Elected 2012
(W) 785-628-5366

fbritten@fhsu.edu


KDADS-Health Occupations Credentialing Licensure
Wendy Davis (785) 296-0061

Wendy.Davis@ks.gov

SLP/A Advisory Board Members
John Ferraro, PhD, Audiology Representative
(W) 913-588-5937

Allison Gatewood, MA, CCC-SLP

agatewood@tps501.org

Ed Schulte, PhD, CCC-SLP (Chair)
(W) 785-354-0767

eschulte@caregiverskansas.com

 

ASHA Standards Change Will Affect Certification

Standard VIII: Beginning with the 2020-2022 certification maintenance interval, all certificate holders will have to earn one of their 30 required CMHs in Ethics.
 
Standard V-E and Standard VII-B: Effective January 1, 2020, clinical supervisors and clinical fellowship mentors for ASHA certification must have at least 9 months of full time work experience and complete 2 hours of professional development/continuing education in clinical instruction/supervision after being awarded the CCC-SLP and prior to supervising or mentoring.


KSHA will work to include these types of continuing education courses in our annual conference and other CE activities. Maintaining your KSHA membership will ensure that you receive notification of these requirements and will allow you to participate in KSHA-sponsored continuing education activities at a reduced rate.

KSHA Website

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President's Message

Allison Gatewood, President

 As another successful KSHA Annual Conference comes to a close, I am reminded that we have so many things to celebrate within our organization and within our professions. It is reinvigorating every year to attend the conference and to have an opportunity to learn during amazing sessions.  I also enjoy the opportunity to spend time with friends from all across the state.  As I return to work, I have new ideas and feel ready to hit the ground running.  I want to thank Anthony and Lara DiLollo for serving as the co-chairs of this year's wonderful conference! The feedback has been very positive, and we know that the conference committee did an excellent job of inviting high-quality, engaging speakers.
 
Aside from attending the wonderful sessions during the conference, the Executive Board also met to work on our plans for KSHA in the upcoming year.  KSHA is beginning the process of renewing its affiliation with ASHA.  The other process we are working on this year is gaining our reaccreditation as an ASHA-approved CEU provider.  In preparation for both of these processes, we have worked to update our code of ethics and made sure that our bylaws are in alignment with ASHA's. We will need your vote to approve a small change in the bylaws regarding our anti-discrimination policy. You will receive a separate email from KSHA regarding this. Please take a minute to read the proposed change and cast your vote by Nov. 7.
 
The other hot topic at the conference this year was SLPA’s in the state of Kansas and their ability to bill Medicaid in the school setting. KSHA  is working hard to advocate for our members with Medicaid, KDHE, and KSDE. Allison Winters, the Vice President of Professional Practices, and the SLPA Task Force have been meeting through conference calls and communicating through emails to make sense of what information we do have and to determine our next steps. As KSHA receives additional guidance and information on this quickly changing topic, we will share information with the membership through email blasts. Please see the article below for more information from Allison Winters.

Looking forward to our next KSHA gathering, our Annual Legislative Day. Mark your calendars now for January 30th. We will meet at Capitol Strategies in the morning, walk over to the Capitol to hear from Bill Brady, KSHA's lobbyist about how best to partner with our legislators, and then participants will have an opportunity to tour the Capitol building, meet with legislators, observe the House or Senate in session, and more. Our luncheon speaker at the KSHA conference, Barbara Jacobson, ASHA Board member, encouraged us to engage in advocacy efforts that protect and promote our professions and those we serve.

 

“Through advocacy you can discover things you didn't know you could do. It’s empowering.” -Dr. Barbara Jacobson

Annual Conference in Review

The 2018 Annual KSHA conference: The Challenge of Change took place October 4-6, 2018 at the Hyatt Regency Hotel in Wichita. The conference was well-attended, with about 460 participants and 29 exhibitors. Many thanks to all of our attendees for coming. The course evaluation forms reflected the quality of the speakers and the variety of topics this year.

The changes to this year's program were well-received overall:

1) The poster session was extended to break times on Friday. Participants enjoyed the flexibility of this, but commented that the space was crowded and congested. We will work on that next year.
2) The Prairie Cup Praxis Bowl was a huge hit! See below for more about that. Join us next year as we see if the champions can hold on to the traveling Cup! Many of you wrote how fun this was, and asked that we continue that. We plan to!
3) We had two pre-recorded sessions this year due to a speaker not being able to join us in-person after the program planning was completed. These sessions were not as engaging as we had hoped. We heard your feedback on those.
4) Cari Ebert's all-day session on Sensory for the SLP was very well-received and we heard your praise for her and recognize the benefit you received from an all-day in-depth dive into a particular topic. We hope to have her back in the future.


Many thanks to the Co-Chairs, Anthony & Lara DiLollo, and the entire Conference Planning Committee, for putting in a lot of work preparing for the conference, and for helping on-site to ensure everything ran smoothly.

The 2019 Conference Planning Committee:

Anthony DiLollo Co-Chair
Lara DiLollo Co-Chair
Gina Riggs Adult/Medical Program
Joanna Wyckoff Adult/Medical Program
Karissa Marble-Flint Pediatric/School Program
Colleen Novak Pediatric/School Program
Angela Bateman and Lara DiLollo Audiology Program
Doug Parham Registration & Moderators
Brian Ray & Stacey Kampe Posters
Carmen Schulte Exhibits
Molly Pierce Hospitality/Publicity
Amanda Popp, Laura Bonin, Marci Watson Food/Beverage
 

Image result for game onFriday evening, after the Poster Session, graduate students from the four Kansas CSD programs had the opportunity to prepare for the Praxis examination in speech-language pathology by using clickers (ARS).

This event was sponsored and coordinated by EBS, in cooperation with KSHA Student Representative, Mackenzie Thrush. Teams from each university were asked sample Praxis questions from various resources including: previous Praxis exams, ASHA SIG’s, as well as study resources in a game show format. Audience members also got a chance to share their opinions and justify their answers. Several faculty members were in the room, and many expressed that the Praxis questions were challenging!

The Bowl was very competitive and it was a close contest. The team from K-State took an early lead, and hung on to it through all the rounds. Congratulations to the Wildcats! The Prairie Cup traveling trophy will be displayed at KSU until next year and the following winning team members will receive a free Praxis registration: Jessica Sutton, Megan Griffith, Ellen Bodine, Ashley Edelman, and Hannah Carlgren (alternate).
To watch a video of the results of first annual Prairie Cup Praxis Bowl, click HERE.

Annual Conference Photos

Conference Planning Committee, from back left: Tony DiLollo, Doug Parham, Laura Bonin, Molly Pierce. Front row, from left: Lara DiLollo, Stacey Kampe, Colleen Novak, Joanna Wyckoff, Karissa Marble-Flint, Angela Bateman, Marci Watson, Mandi Popp. (not pictured: Gina Riggs, Brian Ray, Carmen Schulte)
Lara and Tony Dilollo chaired the 2018 conference. Doug Parham (right) handled the Registration Table and Moderators. These three leaders worked hard to make the conference run smoothly. 
The Audiology Learning Lab, presented by Starkey Hearing Technologies, included a hands-on modification workshop. Participants had fun learning how to modify hearing instruments in the office. In a competitive hearing aid market, this skill is a good one to have!
Poster sessions were extended to morning and afternoon breaks on Friday. This allowed more opportunities to view posters throughout the day.
Exhibitors added to the conference experience. We were happy to share their products and services with our attendees.












To view more conference photos, click HERE.

Annual KSHA Awards

Join us in congratulating the following winners of the annual KSHA awards. Kansas is fortunate to have such passionate clinicians who pursue excellence in their practice.

Lara DiLollo, AuD, CCC-A,  Audiologist of the Year. She was nominated by Mandi Popp, who remarked,

"Lara is an amazing audiologist who is always willing to help out in any way that she can.  At any meeting we have she is always giving suggestions on how we can improve on how we provide services in our district.  Lara cares for her students and makes sure they have all have the best auditory access possible and advocating for their needs."


Kris Pedersen, SLP.D., CCC-SLP, Honors of the Association. She was nominated by Jane Wegner, who wrote,

"I believe her contributions to KSHA and her advocacy for children and families make her an outstanding candidate for this award.

Kris has played many roles within KSHA.  One critical role was serving as President of KSHA from April 2015 until September 2016.  Kris took over the duties of president almost 6 months before her term was to begin and KSHA operations never missed a beat.  She led, and still leads, the KSHA Branding and Website Committee and we have all benefited from the changes made.  She led the Executive Director search which led to hiring Susie, which has led to more efficient and effective services for KSHA members.  Other ways Kris has contributed to KSHA include: KSHA Speech-Language Pathology Assistant Task Force Member; KSHA 2015 Annual Conference Program Committee, Program Organizer; 2015 Legislative Day organizer; and VP of Communications, 2012-2014."

Senators Laura Kelly, Barbara Bollier, and Vicki Schmidt received Special Service Awards. Sen. Lynn Rogers, candidate for Lt. Governor, accepted Sen. Kelly's award at the annual luncheon while Sen. Kelly was on the campaign trail. Senators Bollier and Schmidt had other events and could not attend this year. The trio of Kansas legislators were nominated by Kris Pedersen, who commented,

"For as long as I have been on the KSHA Executive Board, these three powerhouse Senators have been a constant presence and support to our members and the clients we serve. They have each supported KSHA through speaking at our annual Legislative Day, touring us through the Capitol and having informal talks about how to advocate for education and health care. They have been steadfast in their advocacy for issues important to KSHA and know how to get things accomplished at the Capitol, working across the aisle and behind the scenes. We know that we can approach these Senators when issues like the telepractice bill or autism insurance bill arise. They have worked hard behind the scenes to support us and those we serve."

Student Scholarships


Congratulations to these outstanding student members and award winners!





Amanda Platt, KU, Margaret Byrne Sarricks Scholarship 










Kyra Martiny, KU, Margaret Byrne Sarricks Scholarship 











Sydney Dinicola, FHSU, Margaret Byrne Sarricks Scholarship 











Katie Hipp, FHSU, Margaret Byrne Sarricks Scholarship & Dixie Heinrich Servant Leadership Award

Welcome New KSHA Board Members

As our annual conference came to a close, we said goodbye to Past President Debra Burnett, VP-Communications Amy Dejmal, and Student Representative Mackenzie Thrush. We welcomed the following new faces to our Executive Board. Please extend your congratulations and your thanks to these individuals who have volunteered to serve. Please also recognize our outgoing Board members for their hard work over the last several years. Their work has helped KSHA meet the goals set forth in our strategic plan.

President-Elect: Julie Gatts, MA, CCC-SLP 













Vice President of Communications: Amy Hocker, MS, CF-SLP






Vice President of Finance: Tammy Gonzales, AuD, FAAA (re-elected & continuing in the position)


Vice President of Audiology: Rochelle (Shelly) Harden Au.D., CCC-A (re-elected & continuing in the position; not pictured)


Student Representative: 
Elizabeth Leatherman, MA, recently received her Master of Arts in speech-language pathology at the University of Kansas and is continuing coursework to pursue her doctoral degree.  Her clinical and research interests are in the area of augmentative and alternative communication, specifically how it is implemented in the school setting and the impact of AAC on families.

SLP-A Update

Allison Winters, VP-Professional Practices

In July 2018, KDHE’s updated LEA Provider Manual was worded to include SLP assistants in Medicaid reimbursement under the supervising SLP license. Since this announcement, SLPs across the state have voiced their concern about their licensure being used to bill for their assistants' services. KSHA has worked with ASHA to voice its opposition to this new wording in the LEA Provider Manual. Kansas Medicaid listened and has since shared that they plan to rescind the new wording that references SLP assistants. We are currently awaiting an official bulletin from Kansas Medicaid to rescind the change in the LEA Provider Manual. To help resolve this issue and address other issues surrounding the use of SLP-As in the state of Kansas, KSHA re-established the SLP Assistant task-force. The task force has had two meetings (one at the annual conference and one over the phone).

The task-force is discussing the possibility of legislative change that would result in SLP-A licensure and is currently exploring what other states have done. We are also actively reaching out to area universities to inquire about the possibility of setting up SLP-A programs within the state. If you are interested in learning more about SLP-As and/or sharing your opinion/experience in this area, please email me and join the Task Force. 

 

Proposed Change to By-Laws

Please check your email inbox for your unique link to vote on the proposed change. Voting ends Nov. 7.

Current version:
Article III.  Code of Ethics
    The Kansas Speech-Language-Hearing Association and all its membership classes subscribe to the Code of Ethics of the Kansas Speech-Language-Hearing Association. The Association shall not discriminate on the basis of race, national origin, religion, age, sex, sexual orientation, gender, gender identification or handicapping condition. All programs and activities of the Association shall be conducted in furtherance of this policy.

Proposed change:
Article III.  Code of Ethics
 The Kansas Speech-Language-Hearing Association and all its membership classes subscribe to the Code of Ethics of the Kansas Speech-Language-Hearing Association. The Association shall not discriminate on the basis of race, national origin, religion, age, sex, sexual orientation, gender, gender identification, ethnicity, disability, culture, language, or dialect. All programs and activities of the Association shall be conducted in furtherance of this policy.
 
Rationale:
 This verbiage is recommended so that KSHA’s by-laws are in alignment with ASHA’s

KCDHH Position for SLP Open

The Kansas Commission for the Deaf and Hard-of-Hearing has a position on its Advisory Board open for an SLP. It is a three-year term. Please contact Robert Cooper for details if you are interested in serving. Click here to begin the appointment process to this board.

Executive Board Meeting Minutes

Amy Dejmal, VP-Communications

            The KSHA Executive Board met Thursday, October 4, 2018  from 11:00 am - 4:00 pm in the Enterprise Boardroom at the Hyatt Regency Hotel in Wichita.  The Strategic Plan was updated with current work done by organization leadership.  In Focus Area 1:  Association Organization and Management, Susie is working on the November 1 deadline to renew our ASHA Affiliation Agreement for our chapter.  The group discussed the KSHA Bylaws, which were reviewed by Meredith.  Minor changes were proposed to match our document language with ASHA’s.  Dena will present changes at the luncheon annual meeting, with a link to be included in the October Connection for the membership to vote on.   In addition, the Code of Ethics was reviewed by Dena and Allison prior to the meeting, with changes proposed to update the Handbook.   Debbie reviewed and provided updated language to the Handbook, including addition of the Student Representative to the Executive Board, as a non-voting member. Updated language was included on the Task Force for Continuing Education and the Legislative Liaisons.  Position descriptions for SEALs, STARS, STAMPs were drafted by Allison and discussed by the group to be added to the Handbook.   Standing committees terms and candidates were discussed.  KSHA finances were reviewed, and investment portfolio funds are noted to have increased.  There was a $400 fee from the ASHA Continuing Education Board, which is reviewed every five years.   CSAP will be held in November in Boston, Debbie and Dena plan to attend.
            In Focus Area 2: Member Relations, current membership is increased from 513 in July to 696.  Susie has made visits to three universities so far in August/September.  Tammy and Dena have helped present to AUD students.  Discussed how to retain current members gained during conference for future financial health of the organization.  Renewal opt-in is a choice on website renewal.  April 1 is the deadline to renew before being dropped.  Susie reported updates on development of online CEUs using the Natalie Douglas presentation on dementia.  There is an opening for an SLP on the Kansas Commission for Deaf/HH. 
             In Focus Area 3:  Advocacy, Legislative Day is planned for January 30, 2019.  ASHA’s State Association Student Advocacy Grant application is due October 12, with awards notice given October 26. Special Service Awards will be presented at luncheon to Senators Barbara Bollier, Vickie Schmidt, and Laura Kelly.  Dyslexia Task Force minutes will be posted on the website under Advocacy for the membership to review.  An update was provided on SLPAs billing Medicaid per an update to the policy manual in July 2018.  Susie and Allison met by phone conference with Medicaid.  SLPs are required to sign off on the billing and supervise 10% of sessions, although language about supervision is unclear.  Medicaid is planning to review the policy and get back in touch with Susie.  An update was provided on SLPs in the Blue Valley School District as their contracts were changed in August unexpectedly.  Meredith connected them with KNEA to help members get protection and understand their negotiation rights. 
            Focus Area 4: Public Relations, social media trends were discussed by the group to drive membership.  A Closed Facebook group that was started in July, “Kansas SLPs & AuDs” has 137 members.  Connection readership is good and there has been positive feedback from Provider Highlights on Facebook.  Students report they use Instagram primarily, then FB, followed by Twitter.  It was discussed to consider using all platforms. 
            In Focus Area 5:  Professional Development and Continuing Education, a planning update was provided for the Wichita conference.  There are 450 attendees registered.  Praxis Bowl is much anticipated for Friday night.  After the conference, Susie will coordinate CEU paperwork to ASHA and comment cards.  The 2019 Conference will be held in Manhattan, tentatively October 3-5 based on the football schedule.  Tara Marshall and FHSU have agreed to chair the conference.  Susie signed the contract for the 2020 conference in Overland Park.  The 2021 conference location was discussed, giving consideration to Topeka.  The sleeping rooms have been updated but the conference rooms have not.  Only 4 hotels in the state can accommodate the meeting rooms needed for annual conference. 
            The Strategic Plans were reviewed.  The EB will draft a new strategic plan in 2019 to keep the organization moving forward.  The next EB meeting will be held in January in Topeka in conjunction with Legislative Day.

KSHA Receives Continued Approval as an ASHA Approved Continuing Educator Provider

ASHA Approved CE Provider Status Demonstrates Commitment to High-Quality CE Programming for Audiologists and Speech-Language Pathologists

The Continuing Education Board (CEB) of the American Speech-Language-Hearing Association (ASHA) recognized KSHA on 10/16/2018 by reapproving them for an additional five years as an ASHA Approved Continuing Education (CE) Provider. ASHA Approved CE Providers are approved to offer ASHA Continuing Education Units (CEUs) for the courses they offer to audiologists and speech-language pathologists. The recognition period extends for five years and includes all courses offered during that time that meet the ASHA CEB standards.

“We are pleased to welcome the Kansas Speech-Langage-Hearing Association as our ASHA Approved CE Provider organization,” Dr. Elise Davis-McFarland, president of ASHA. Davis-McFarland added, "KSHA joins 540 organizations across the county and around the world that have had their organizational process and courses reviewed by our experts in continuing education to ensure the highest possible standards are met.”

In order to achieve ASHA Approved CE Provider status, KSHA completed a rigorous application process and successfully demonstrated adherence to the ASHA Continuing Education Board standards that focus on the design, development, administration, and evaluation of its continuing education courses offered for audiologists and speech-language pathologists. The re-approval process involved the review of all courses offered by KSHA in the past five-year period and their on-going adherence to ASHA CEB standards. As a result of re-approval, KSHA agreed to continue their compliance with ASHA CEB standards and can continue to promote their organization and courses using the ASHA CE logo on promotional course material. In addition, KSHA is listed on the ASHA CEB’s Approved CE Provider list and their courses that meet CEB standards appear in the ASHA CEFind on the ASHA website at www.asha.org/CE/.

As part of the process, KSHA was asked to update its Cooperative Course Policy, which can be viewed here. One notable change is the timeline for submission of documents to KSHA for cooperative courses. The deadline has changed from 45 days before course offering to three months before the course offering. This change will allow KSHA to have a more active role in the planning of the course. If you are interested in offering ASHA CEUs for a course, please contact KSHA to initiate the process.

 

KSHA works with Kansas Medicaid on Telepractice

During the 2018 legislative session, KSHA worked hard to get SLPs and Audiologists added to the list of providers on the Kansas Telemedicine Act (Senate Sub for HB 2028). This bill was passed, and both professions are included in the list of providers who are able to bill Medicaid for services delivered via telepractice. Kansas Medicaid is currently writing the regulations for this bill, which is scheduled to go into effect Jan. 1, 2019.

Kansas Medicaid asked KSHA to submit a list of CPT codes that could be included in the regulations as billable codes for telepractice services because their initial plan was to include just three SLP codes, and no Audiology codes. The three SLP codes were those included in a pilot program that was implemented by Greenbush Education Service Center prior to the passage of the bill.


 KSHA collaborated with ASHA, AAA, KU, Greenbush and practicing Kansas clinicians to develop the following recommendations to Kansas Medicaid:

It is our recommendation that Kansas Medicaid does not limit which speech-language pathology and audiology codes are reimburseable when delivered via telepractice. With advances in technology, the use of a technician at a remote site, and rapid changes to codes, placing limits on billable codes would restrict access to services needed by Medicaid beneficiaries. The same CPT codes can be used when delivering services via telepractice as when delivered in-person. The intent of the legislation was not to limit the coverage to certain codes.
 

KSHA also provided a list of SLP codes and a list of Audiology procedures that can be performed via telepractice (and a list of those that are not feasible to deliver remotely) in order to justify their inclusion in the regulations. At this time, KSHA has not received any feedback from Kansas Medicaid on the recommendations. We will pass along the finalized regulations to our members once they are available from Medicaid.

Audiology Updates

Rochelle Harden, VP-Audiology

OTC Hearing Aid Act of 2017:

A Consensus Paper was submitted to the FDA from The Working Group, comprised of leaders from the American Academy of Audiology (AAA), Academy of Doctors of Audiology (ADA), American Speech-Language-Hearing Association (ASHA), and International Hearing Society (IHS). This document was put together to give suggestions from these groups after months of discussion about this topic. The Working Group’s Consensus Paper offers five key recommendations regarding the OTC Hearing Aid Act of 2017 and suggestions on how to incorporate those recommendations into the rule. The Consensus Paper includes scientific evidences and data to support their recommendations.


The following are the Five Key Recommendations that were made followed by a link the Consensus Paper in its entirety on the ASHA website. The following is taken directly from the Regulatory Recommendations for OTC Hearing Aids: Safety & Effectiveness document Aug. 2018 on the ASHA website.
 
Five recommendations have been identified as key to provide enough reassurance of safety and effectiveness and of consumer protection: 
 

Recommendation 1:
FDA to establish product requirements appropriate for OTC hearing devices targeting mild‐to moderate hearing impairment. In particular, the  Working Group recommends that: a) the 2cc coupler HFA  full on gain, as measured  at an input level of 50 dB SPL per ANSI S3.22‐2014, is 25 dB or lower; and b) the peak  (or maximum) 2 cc coupler OSPL90, per ANSI S3.22‐2014, is not greater than 110 dB  SPL, in combination with input compression and volume control. In addition, the use of instant‐fit ear‐tips is encouraged.   

Recommendation 2: 
FDA to define concise, outside‐of‐the‐box labeling appropriate for medical devices sold over‐the‐counter.  This should include recognition of intended use/usage and an important notice for the prospective users about hearing loss being a medical condition best addressed in consultation with a licensed professional.   

Recommendation 3: 
FDA to define comprehensive, inside-the-box labeling including a strong warning that the device is not intended for children under the age of 18. Additionally, inside-the-box should include a User Instruction Manual with direction to the consumer on how to identify lack of benefit and what to do.

Recommendation 4:  
FDA to name the new category as “Self-Fit Over-the Counter Hearing Devices” and to maintain for such category the same risk classification as air conduction hearing aids – i.e. Class I for non-wireless devices and Class II (exempt) for wireless OTC hearing devices. Additionally, the Working Group strongly recommends that any 510(k) exemptions be limited to devices that have received a first-time FDA marketing authorization (a 510(k) clearance).  The initial OTC air conduction hearing devices should be required to undergo the 510(k) processes.

 

Recommendation 5: 
FDA, in coordination with the FTC, to establish strong consumer protection laws (e.g. return and refund policies, unsubstantiated and false claims, …) and put in place adequate processes and resources to enforce them, especially in the first years of introduction of the new category.

Survey Participation Requested

Speech-language pathologists working in an early childhood or school setting are invited to take part in a survey to help researchers from the University of Kansas Medical Center and the University of Missouri learn about experiences in assessment and intervention with children with reading and writing difficulties. Your answers will help us to understand what school speech-language pathologists are doing in practice. This survey will take approximately 10-15 minutes to complete; no identifying information will be collected.
https://qtrial2018q2az1.az1.qualtrics.com/jfe/form/SV_2bPmTCoaLfab2PH

 
Connection - October 2018 Connection