Robert M. DiSogra, Au.D., FAAA
Audiology Consultant
7 Nurko Rd
Millstone Twp., NJ 08535
908.415.6731 (v)e-mail:
TOPIC DURATION (in hours)
Pharmaceuticals and Nutraceuticals 3.0
for Hearing Loss and (two 90 minute sections)
Tinnitus (Part I and II)
This can be an ABA Tier 1 CEU Program
Abstract
The number of pharmaceuticals available to manage hearing loss and/or tinnitus continues to grow. This program reviews the current pharmaceutical research for hearing loss and tinnitus as well as reviewing the efficacy and safety OTC tinnitus relief products. Patient management strategies are also reviewed. (Word Count: 44)
Statement of the topic
Hearing loss and/or tinnitus can be side effects of over several hundred drugs. Establishing a time line is critical to determine of the patient with hearing loss and/or tinnitus is experiencing an adverse event.
Patients sometimes will not report these side effects to the prescribing physician and may chose to self medicate the problem – especially tinnitus – with over-the-counter products.
Over 80 products are available claiming relief or a cure for tinnitus however none of these products are FDA approved. These herbals/supplements/vibratory devices, laser lights and essential oils are all are available in health food stores and on-line with limited regulation but no FDS approval. Of concern is that only 10% of the combined total number of herbal ingredients/compounds have peer reviewed research. The other 90% of the ingredients have no published research related to tinnitus.
Audiologists need to be aware of these products and their potential harm to some of their patients.
Importance or relevance to attendees
Patient counseling and other management strategies will be presented in order for attendees help their patients make informed decisions about starting or discontinuing an OTC tinnitus relief product.
References are given along with a list of websites for additional information to help manage the tinnitus patient.
SUMMARY
There are many FDA approved pharmaceuticals that have been used to manage hearing loss and/or tinnitus regardless of the etiology of the problem. Several new drugs that are currently undergoing clinical trials are showing promise with certain hearing loss etiologies (i.e., noise induced hearing loss).
Several off-label drugs are also being used for hearing loss/tinnitus management. For example, valium, an antidepressant drug, has been used with limited success with tinnitus patients.
However, the FDA loosely monitors over-the-counter (OTC) nutraceuticals (i.e., vitamin supplements) and classifies nutraceuticals as ‘food.’ This means that efficacy and safety do not have to be demonstrated. The scientific guidelines for evidence-based clinical research do not apply.
Patients who are prescribed pharmaceuticals for tinnitus are under the care of a licensed physician, however, there are some patients can self-medicate with OTC products.
Management strategies differ greatly with pharmaceuticals and nutraceuticals.
There are over 80 products available without prescription for hearing loss and tinnitus. This program reviews several of these product's ingredients that are contraindicated for some patients or could cause other health problems.
This program summarizes the current pharmaceutical research for hearing loss and tinnitus management as well as offering strategies for patients who self-medicate with over-the-counter supplements.
This instructional course is divided into two (2) ninety (90) minute programs:
Part I – Pharmaceutical for Hearing Loss and Tinnitus
Attendees will learn how the U.S. Food and Drug Administration (FDA) closely regulates pharmaceutical clinical trials.
The program continues with an overview of how a drug manufacturer goes from the “proof of concept” phase to the different clinical trial phases before final FDA approval (if approved at all).
Next, a comprehensive review of the drugs that cause hearing loss is presented. The section continues with a comprehensive review of different FDA approved medications used primarily for hearing loss and/or tinnitus as well as several off-label drugs used for the same problem. This section encompasses the biochemistry and pharmacology involved with cochlear hearing loss/tinnitus.
NOTE: Patient management strategies and suggestions for improved communication with the prescribing physician and family pharmacist are summarized at the end of Part II.
Part II – Nutraceuticals for Hearing Loss and Tinnitus
The Dietary Supplement and Health Education Act (DSHEA) of 1994 allows nutraceuticals manufacturers to make statements of their product’s efficacy and safety to influence public opinion without having to back up their claims with evidence-based research.
The Federal Trade Commission (FTC), along with the FDA, share responsibility of efficacy and safety of nutraceuticals however these agencies put the burden of proof on the manufacturer. Using the disclaimer “These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease” opens the door for opportunity to not only market the product but also give false hope to patients experiencing tinnitus.
Attendees will not only learn which federal and commercial websites provide accurate drug information but also learn about how several of the 80 known over-the-counter (OTC) products that claim tinnitus relief (and in some cases a cure) can be more harmful than helpful with certain patient populations.
The last section of this program will review both pharmaceutical and nutraceutical management strategies which could be helpful to the patient, their family, the prescribing physician and pharmacist.
Suggestions for improved communication between audiologist, patient and primary care physician (or ENT) and pharmacist will be made.
NOTE: The program offers several handouts for future reference. (Word count: 539)
TIME ORDERED AGENDA (in minutes):
Part I
0:00 – 0:10 Introduction/Review Learner Objectives
0:10 – 1:30 Review of pharmaceuticals for hearing loss and tinnitus (research and
FDA approved products)
NOTE: Part II summarizes patient management (see below)
Part II
0:00 – 0:10 Introduction/Review Learner Objectives
0:10 – 1:10 Review of nutraceuticals/over-the counter products for hearing loss
and tinnitus
1:10 – 1:30 Patient management strategies for pharmaceuticals and nutraceuticals,
Summary, Q & A
Detailed Time Ordered Agenda (in minutes) – all times approximate
0:00 - 0:10Introduction/Overview
0:10 - 0:20Getting a Drug Through Clinical Trials
0:20 - 0:40Identifying Adverse Drug Reactions/Incidence Figures
0:40 - 0:50Development of Nutraceuticals
0:50 – 1:00Role of the FDA and FTC for Both Pharmaceuticals and Nutraceuticals
1:00 – 1:15Vitamins for Tinnitus – Past and Current Research
1:15 – 1:30Herbals for Tinnitus – Historical Review
1:30 – 2:10Over-The-Counter Tinnitus Relief Products (including Apps) Currently Available
2:10 – 2:30Efficacy and Safety Data
2:30 – 2:50Patient Management
2:50 – 3:00Summary and Q&A
LEARNER OBJECTIVES: (please note that objectives need to follow ASHA guidelines, additional information on writing measurable objectives are available on the ASHA website).
Learner Outcomes (Long)
After this presentation, participants will be able to:
- Identify current pharmaceutical research for hearing loss and tinnitus;
- Identify nutraceuticals recommended for hearing loss and tinnitus;
- Understand the FDA loophole that allows supplement manufacturers to make claims of efficacy without having to proved scientifically efficacy and safety;
- Recognize which herbals have efficacy and safety data published in peer reviewed journals;
- Improve communication between patient and referring physician concerning adverse drug or OTC tinnitus relief product side effects;
- Know how to report an adverse herbal/supplement reaction to the FDA.
Learner Outcomes (short)
After this program is completed, attendees will be able to:
1. Identify pharmaceuticals used for hearing loss and tinnitus management;
2. Identify nutraceutical/over-the counter products marketed for hearing loss and tinnitus
management;
3. Improve patient management strategies with patients using these compounds;
Biography
Robert M. DiSogra, Au.D, is an independent audiology consultant in Millstone Twp., NJ. He had been in private practice for 30 years in Freehold, NJ until 2015.
He received his Doctor of Audiology degree in 2003 from the Osborne College of Audiology at Salus University in Elkins Park, PA. He holds a Masters Degree in Audiology from Hofstra University and a Bachelor's Degree in Speech Education from St. John's University.
Dr. DiSogra developed and taught the Pharmacology/Ototoxicity distance learning course at Salus University for five years and is an adjunct lecturer at Salus. He has also taught doctoral level/graduate and undergraduate Audiology courses at St. John's University, Rutgers University and Kean University (NJ).
Dr. DiSogra was the 2016 recipient of the Dr. Joel Wernick Award for his educational contributions within the fields of audiology and hearing science from the Academy of Doctors of Audiology. He was also recognized as the 2013 Alumnus of the Year from Salus University. He currently serves as Chairperson of the Osborne College of Audiology Advisory Board at Salus University.
Dr. DiSogra is US Navy veteran and served during the Viet Nam era.