Patient Care | December 2018 Hearing Review
To maintain consumer safety while dispensing hearing aids and other hearing amplification devices when licensed providers are not involved, a multidisciplinary research team developed the Consumer Ear Disease Risk Assessment (CEDRA) questionnaire, which is designed to identify the risk of diseases with ear and hearing symptoms. The free questionnaire is self-administered, scored by consumers, and available at http://cedra.northwestern.edu.
Policies regulating the provision and acquisition of hearing aids have substantially changed in the United States. In December 2016, the US Food and Drug Administration (FDA) announced it would no longer enforce the medical evaluation/waiver provision for acquiring a hearing aid.1 In August 2017, the President signed the Warren-Grassley Over-the-Counter Hearing Aid Act of 2017 into law, which mandates the FDA to create an OTC hearing aid category for individuals, “without the supervision, prescription, or other order, involvement, or intervention of a licensed person” (S.670).2,3 These modifications have provoked trepidation and outright opposition among some in the hearing healthcare community. Many conditions and diseases can include hearing difficulty as a symptom,4 and some of these diseases have the potential for serious adverse health consequences.
Previously published red flags—potential contraindications to hearing aid use—have been defined by the FDA in 1977 (21 CFR 801.420)5 and further elaborated on by the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) in 2014.6 Red flags alert providers to patients who may be at higher risk for disease and require further medical evaluation and management. But red flags are used only by providers of hearing healthcare services and are of no help in provider-free, direct-to-the-consumer (DTC) and OTC markets.
CEDRA for Better Safety in OTC/DTC Hearing Aid Delivery
Our multidisciplinary team of researchers, clinical audiologists, and otolaryngologists created CEDRA to detect the presence of 104 targeted ear diseases (TEDs).7 We initially designed CEDRA for an adult consumer considering hearing aids for the first time, but it can be used to screen consumers seeking any hearing amplification device. It has been tested with 307 patients at the Mayo Clinic in Jacksonville, Fla,7 and we are currently validating it in a larger sample of patients at several US sites.
CEDRA is a 15-item questionnaire with yes/no and multiple-choice questions. Most questions relate to hearing and balance, one question relates to general health, and the remainder query non-otological symptoms, such as vision impairment or recurring fever that co-occur with hearing issues in some TEDs. Anecdotally, most patients find CEDRA relatively easy to complete and can easily answer all questions in less than 10 minutes.
The third page of CEDRA displays the scoring algorithm. It is a simple summation of “yes” responses to most questions, along with a dichotomization of the few scalar questions. Consumers can use the third page to calculate their CEDRA score or use a web-based CEDRA for automated scoring.
Based on our training sample, CEDRA makes recommendations for consumers to see a doctor if the score is 4 or greater. This cut-off provided the best specificity (72%) while maintaining an adequately high sensitivity (90%). For comparison, Klyn et al8 found, in the same sample, that the FDA red flags, which require a provider for assessment, had similar test characteristics (FDA specificity = 72%; FDA sensitivity = 91%).
CEDRA is a tool designed for consumers to easily and inexpensively assess their risk of ear disease and we designed it with the intention of maintaining safety while increasing the accessibility of hearing health care. It offers an opportunity for consumers to self-screen for disease before seeking a hearing device. Audiologists and hearing aid specialists may also use CEDRA to help their patients decide the appropriate path to follow in hearing healthcare, whether it be medical intercession or the acquisition of hearing aids.
CEDRA is free to use and is available online at http://cedra.northwestern.edu with automated scoring and as a downloadable pdf document. The site also contains references to relevant research publications and a list of research team members who developed CEDRA. A Spanish version of CEDRA will soon be available on the same site.
CEDRA was developed with funding from the Knowles Center at Northwestern University and the NIH/NIDCD (R21/R33 DC013115). The principle investigators were Sumitrajit Dhar, PhD, and David Zapala, PhD, and the research team included Razan Al Fakir, AuD, PhD; Jamie Bogle, AuD, PhD; Deborah Carlson, PhD; James Griffith, PhD; Niall Klyn, PhD; Larry Lundy, MD; Donald Nielsen, PhD, and Samantha Kleindienst Robler, AuD, PhD.
FDA eliminates ‘physician waiver’ system in hearing aid dispensing. December 7, 2016. Available at: http://www.hearingreview.com/2016/12/fda-eliminates-waiver-system-patients-obtain-hearing-aids
President Trump signs OTC hearing aid legislation into law. August 19, 2017. Available at: http://www.hearingreview.com/2017/08/president-trump-signs-otc-hearing-aid-legislation-law
Warren E, Grassley C. S.670-115th Congress (2017-2018): Over-the-Counter Hearing Aid Act of 2017. August 2017. Available at: https://www.congress.gov/bill/115th-congress/senate-bill/670
Kleindienst SJ, Dhar S, Nielsen DW, Griffith JW, Lundy LB, Driscoll C, Beatty C, Barrs D, Zapala DA. Identifying and prioritizing diseases important for detection in adult hearing health care. Am J Audiol. 2016;25(3):224. Available at: https://doi.org/10.1044/2016_AJA-15-0079
US Food and Drug Administration (FDA). 21 C.F.R. 801.421: Hearing aid devices; conditions for sale. 1977. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=801.421
American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS). Position Statement: Red Flags Warning of Ear Disease. Alexandria, Va: AAO-HNS; 2014. Available at: http://www.entnet.org/?q=node/912
Kleindienst SJ, Zapala DA, Nielsen DW, Griffith JW, Rishiq D, Lundy L, Dhar S. Development and Initial Validation of a Consumer Questionnaire to Predict the Presence of Ear Disease. JAMA Otolaryngol Head Neck Surg. 2017;143(10)[Oct 1]:983-989. Available at: https://doi.org/10.1001/jamaoto.2017.1175
Klyn NAM, Kleindienst SR, Alfakir R, Nielsen DW, Griffith JW, Carlson DL, Lundy L, Dhar S, Zapala DA. A retrospective estimate of ear disease detection using the “Red Flags” in a clinical sample. Ear Hear. 2018;39(5)[Sept/Oct]:1035-1038. Available at: https://doi.org/10.1097/AUD.0000000000000561
CORRESPONDENCE can be addressed to Dr Nielsen at: [email protected]
About the author: Donald Nielsen, PhD, is the principal of Don Nielsen Consulting, Columbus, Ohio. Over the last 30+ years, he has held executive positions at several world-renowned audiology research centers, including Henry Ford Hospital, House Ear Institute, and the Central Institute for the Deaf, and currently serves as an Audiology University Advisor for the Fuel Medical Group.
Original citation for this article: Nielsen DW. CEDRA: A consumer questionnaire to detect disease risk before hearing aid purchase. Hearing Review. To be updated. Scheduled for December 2018 print publication. Online first November 20, 2018.