Harvey Abrams PhD

“Peeling the Onion” is a monthly column by Harvey Abrams, PhD.

 

I received a notice in my mailbox earlier this week informing me that there was $9.75 postage due on a package that my town post office was holding for me. For the life of me, I couldn’t figure out what it could be.

 

Mystery Mail

 

I suspected it had to do with some forwarded mail (I move around a lot) and for $9.75, it must have been a pretty big or heavy package. So, I went to the post office the next day to find out what it was and who sent it. It was a box (not too heavy) and, as I suspected, it was forwarded from my previous address (apparently the recipient is responsible for the costs associated with forwarding parcel post items) but the sender’s information was of no value for identification purposes.

I couldn’t figure out what was in that box or who sent it and I had to pay the postage due to open the package. Now, what do I do? Do I pay the $9.75 to find out what’s inside or do I tell the post office that I refuse delivery and always wonder what possible “treasure” I might have passed up?

 

No Segue but Keep Reading

 

On June 9th, I attended a stakeholder’s meeting in Washington, D.C. that was to serve as a follow-up to the National Academies of Science, Engineering, and Medicine (NASEM’s) publication of Hearing Health Care for Adults: Priorities for Improving Access and Affordability. The details of the meeting have been reported in Hearing Health & Technology Matters and elsewhere. The specific objectives of the meeting were to:

  • Facilitate discussion on strategies for a multi-pronged approach to improve hearing health care access and affordability;
  • Identify needs, barriers, and opportunities for action on hearing health care; and
  • Brainstorm about new and future actions and

Much of the morning was devoted to participating in 4 breakout sessions: Public Awareness and Consumer Measures, Quality Metrics and Health Professional Education, Innovation in Services – Accessibility and Affordability, and Consumer Comparisons – Evaluation Criteria and Standardized Terminology.

 The afternoon session, however, was devoted to discussion of a “For Discussion Draft” document prepared by the Federal Food and Drug Administration (FDA) entitled: “OTC Hearing Devices – Starting Points for Discussion at the June 9, 2017 Stakeholder Meeting”.  Here we had the “starting points” for what might ultimately lead to a FDA regulation pertaining to a new classification of over-the-counter (OTC) hearing aids (assuming, of course, they are directed to do so following the passage of current legislation in the House and Senate and the signing of that legislation into law by the President).

The discussion items for the afternoon session were broken down into 3 major categories:

  • On the package labeling
  • Safety Requirements for Manufacturers
  • Considerations for Quality

This last category consisted of a list of some 20 features (e.g. distortion, noise reduction, directionality, connectivity, etc.) and the focus of the discussion involved the extent to which these features should be required, if there should performance standards associated with each (or some), if the information associated with these features should be made available to consumers and, if so, how. Needless to say, there was considerable discussion (and some disagreement) among the stakeholders (academicians, hearing aid industry representatives, consumer electronics industry representatives, and patient advocate representatives).

Not surprisingly, we didn’t come to any decisions on most of the draft discussion items in the few hours available to us.

 

Still With Me Here?

 

So, what does this all have to do with my ‘postage due’ dilemma? If you’ve been following my posts for the last year or so, you’ve been on an OTC journey with me, which include the PCAST reporst, NASEM’s support of OTC hearing aids, the FDA and FTC meetings, and recent legislative efforts associated with OTC hearing aids.

All of the above has been a very costly process involving considerable time and labor invested by stakeholders and staff members involved in multiple task forces and committees, attendance at meetings, responses to published reports, promulgation of legislation, lobbying efforts in support of and opposed to the pending OTC legislation, the hundreds of articles written in, what appears to be, every small and large town newspaper across the country.

 

Our Mystery Package

 

http://www.systemsolutionsdevelopment.com/snail-mail-and-the-mystery-box/From my perspective, we appear to be inexorably moving toward the adoption of an FDA regulation on OTC hearing aids. I don’t believe there is another example of FDA approving a medical device (or, more accurately, a delivery system for a medical device) for which there is so little evidence for its safety or efficacy. Similar to my ‘postage due’ experience, it seems to me that we are paying to see what’s inside this “OTC” package because we just don’t know what it contains, do we? We don’t know whether the contents of this box will yield improvements in hearing healthcare accessibility and affordability, or if what we find inside is simply not worth what we’re paying.

Ironically, just a few days before the June 9th stakeholder’s meeting, NASEM published a report entitled, “The Promise of Assistive Technology to Enhance Activity and Work Participation.” Chapter 5 is devoted to “Selected Hearing Technologies”.  It’s an excellent review of the technologies available to and barriers experienced by people with hearing loss. Among its conclusions is the following:

Proper fitting and training are complex but necessary elements of maximizing performance among users of hearing devices. Consumers who work with providers trained in the use of properly prescribed and fitted hearing devices can expect better results than those who use off-the-shelf products.

 

My Mystery Mail

 

I paid my $9.75 to the post office to find out what was inside that package. It turned out to be some marketing materials for a cerumen removal product.  

 

 

Harvey Abrams, PhD, is a consulting research audiologist in the hearing aid industry. Dr. Abrams has served in various clinical, research, and administrative capacities in the industry, the Department of Veterans Affairs and the Department of Defense. Dr. Abrams received his master’s and doctoral degrees from the University of Florida. His research has focused on treatment efficacy and improved quality of life associated with audiologic intervention. He has authored and co-authored several recent papers and book chapters and frequently lectures on post-fitting audiologic rehabilitation, outcome measures, health-related quality of life, and evidence-based audiologic practice.  Dr. Abrams can be reached atharvey_abrams@starkey.com

images from system solutions development and Ross Land/Getty

 

Made for iPhone hearing aids came first and most smart hearing aids are still not “made” for android devices. The Internet of things reachable by hearing aids is limited to a small, picky universe. In the larger universe, my android phone and Samsung washing machine may be having lively discourse, but I’m not privy to their chats via my hearing aids.

I don’t really want to talk to my home appliances, but who knows what they’re plotting? 

 

Samsung to the Rescue

 

Samsung plans to fix this, noting in its patent #9654906 that there is a need to remedy

certain limitations existing in Android platform implementations.

Samsung’s solution is an electronic device comprising a processor coupled to a Bluetooth control module which stores a “modified Bluetooth Low Energy (BLE) protocol stack” of  a “plurality of audio-related commands (ATT)”. 

In that structure, “first and second” audio-related commands (ATTs) are transmitted at the same time (see flow chart labeled “Fig 6” from the patent). For example, if the electronic device is a hearing aid, the first and second ATTs could be a “media task layer and a hearing aid application layer.”

The Samsung universe of electronic device candidates with communication functions is huge and spelled out in the patent. The list is long but worth reprinting here, just to bring home the Samsung vision of non-stop communication bombardment.

 “… a smartphone, a tablet Personal Computer (PC), a mobile phone, a video phone, an electronic book (e-book) reader, a desktop PC, a laptop PC, a netbook computer, a Personal Digital Assistant (PDA), a Portable Multimedia Player (PMP), an MP3 player, a mobile medical appliance, a camera, and a wearable device (e.g. a Head-Mounted-Device (HMD) such as electronic glasses, electronic clothes, an electronic bracelet, an electronic necklace, an electronic appcessory, electronic tattoos, or a smart watch)…

 a smart home appliance with a communication function [including]… a television, a Digital Versatile Disk (DVD) player, an audio, a refrigerator, an air conditioner, a vacuum cleaner, an oven, a microwave oven, a washing machine, an air cleaner, a set-top box, a TV box,… a game console, an electronic dictionary, an electronic key, a camcorder, and an electronic picture frame.

… medical appliances (e.g. Magnetic Resonance Angiography (MRA), Magnetic Resonance Imaging (MRI), Computed Tomography (CT) machine, a movie camera, and an ultrasonic machine), navigation devices, Global Positioning System (GPS) receivers, Event Data Recorders (EDRs), Flight Data Recorders (FDRs), automotive infotainment devices, electronic equipment for ships (e.g. navigation equipment for ships, gyrocompasses, or the like), avionics, security devices, head units for vehicles, industrial or home robots, Automatic Teller Machines (ATM), and Point Of Sales (POS) systems…

.at least one of a part of furniture or a building/structure having a communication function, an electronic board, an electronic signature receiving device, a projector, and various kinds of measuring instruments (e.g., a water meter, an electric meter, a gas meter, a radio wave meter, and the like). The electronic device … may be a combination of one or more of the aforementioned various devices…. may be a flexible device….[and] is not limited to the aforementioned devices.”

 

The May List

 

Description

Patent Number

Assignee

Issued

Water resistant acoustic port in ear-mouthed hearing device

9636259

3M Innovative Properties Company (St. Paul, MN)

5/02/2017

Unobtrusive firmware updates for hearing assistance devices

9639342

Starkey Laboratories, Inc. (Eden Prairie, MN)

5/02/2017

Method and apparatus for hearing assistance in multiple-talker settings

9641942

Starkey Laboratories, Inc. (Eden Prairie, MN)

5/02/2017

Method of tuning capacitance for hearing assistance device flex antenna

9641944

Starkey Laboratories, Inc. (Eden Prairie, MN)

5/02/2017

Bluetooth hearing aid system

9641945

UBDevice Corp. (Taoyuan, TW)

5/02/2017

Binaural hearing device and method to operate the hearing device

9641946

Sonova AG (Stafa, CH)

5/02/2017

Electrical feedthrough assembly

9643021

Advanced Bionics, AG (Staefa, CH)

5/09/2017

Utilization of different loudness encoding schemes in cochlear implant systems

9643007

Advanced Bionics, AG (Staefa, CH)

5/09/2017

Practitioner device for facilitating testing and treatment of auditory disorders

9642573

Zhao, Yong D & Zhao, Jennifer J (Simi Valley CA)

5/09/2017

User interfaces of a hearing device

9643018

Cochlear Ltd (Macquarie University,  NSW, AU)

5/09/2017

Hearing instrument comprising a rechargeable power source

9647462

Sonova AG (Stafa, CH)

5/09/2017

Wireless communication method and apparatus of hearing device

9648428

Samsung Electronics Co., Ltd. (Suwon-si, KR)

5/09/2017

Hearing assistance device with improved microphone protection

9648429

Starkey Laboratories, Inc. (Eden Prairie, MN)

5/09/2017

Learning Hearing Aid

9648430

GN Hearing A/S (Ballerup, DK)

5/09/2017

Adjusting a volume level of a phone for a detected hearing aid

9654618

International Business Machines Corp (Armonk, NY)

5/16/2017

Method of fitting a hearing instrument, and impression tool

9654884

Sonova AG (Stafa, CH)

5/16/2017

Methods and apparatus for allocating feedback cancellation resources for hearing assistance devices

9654885

Starkey Laboratories, Inc. (Eden Prairie, MN)

5/16/2017

Hybrid hearing instrument connector

9654886

Sivantos Pte. Ltd. (Singapore, SG)

5/16/2017

Hearing aid adapted for embedded electronics

9654887

Starkey Laboratories, Inc. (Eden Prairie, MN)

5/16/2017

Personal hearing device

9654888

Axil, LLC. (Draper, UT)

5/16/2017

Hearing aid having combined antennas

9661426

GN Hearing A/S (Ballerup, DK)

5/23/2017

Hearing aid with inductively coupled electromagnetic resonator antenna

9661427

Starkey Laboratories, Inc. (Eden Prairie, MN)

5/23/2017

General purpose device to assist the hard of hearing

9662245

International Business Machines Corp (Armonk, NY)

5/30/2017

Hearing device with improved low frequency response and method for manufacturing such a hearing device

9668067

Sonova AG (Stafa, CH)

5/30/2017

Hearing device and external device based on life pattern

9668069

Samsung Electronics Co., Ltd. (Suwon-si, KR)

5/30/2017

Hearing device with model control and associated methods

9668071

GN Hearing A/S (Ballerup, DK)

5/30/2017

images fro klehanie, puppet studio