Sudden sensorineural hearing loss (SSNHL) is 1 of

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1 Original Research Otology and Neurotology Sudden Sensorineural Hearing Loss in the Department of Defense Charlotte K. Hughes, MD, MPH 1, Jakob Fischer, MD 2, Carlos R. Esquivel, MD 1,3, and Adrienne M. Laury, MD 1 Otolaryngology Head and Neck Surgery 2018, Vol. 159(2) Ó American Academy of Otolaryngology Head and Neck Surgery Foundation 2018 Reprints and permission: sagepub.com/journalspermissions.nav DOI: / No sponsorships or competing interests have been disclosed for this article. Abstract Objective. The American Academy of Otolaryngology Head and Neck Surgery Foundation clinical practice guideline (CPG) proposes recommendations regarding sudden sensorineural hearing loss (SSNHL). SSNHL is managed by primary care, emergency medicine, and otolaryngology providers in the Department of Defense (DoD). However, their adherence to this CPG is unknown. We sought to determine provider compliance and identify areas for improvement. Study Design. Case series with chart review. Setting. DoD s electronic medical record. Subjects and Methods. Patients with SSNHL (N = 204) were treated between March 1, 2012, and September 30, Time from onset of symptoms to evaluation by primary care, emergency department, audiology, and otolaryngology providers and treatments were analyzed. Results. The average interval from onset of symptoms to evaluation by a primary care or emergency department provider was 4.86 days (95% CI, ). Time from presentation to ear, nose, and throat and audiologic evaluation was days (95% CI, ) and days (95% CI, ), respectively. Diagnostic workup included magnetic resonance imaging (n = 150, 73.5%), computed tomography (n = 28, 13.7%), and laboratory testing (n = 50, 24.5%). Oral steroids were used in 137 (67.2%) patients, with 78.8% treated with the recommended dose. Intratympanic steroids were utilized in 65 (31.9%) patients, with variable dosing. Conclusion. The DoD is uniquely positioned to evaluate adherence to CPGs on national and international levels given the robust and standardized electronic medical record. Areas of improvement include timely identification of SSNHL with rapid referral to ear, nose, and throat and audiology providers; minimizing unnecessary imaging, laboratory testing, and medications; and correct dosing of oral and intratympanic steroids. Keywords sensorineural hearing loss, sudden sensorineural hearing loss, hearing loss, Department of Defense, quality improvement, patient safety, otolaryngology Received October 29, 2017; revised February 12, 2018; accepted March 13, Sudden sensorineural hearing loss (SSNHL) is 1 of only a few otologic emergencies, yet it is not a rare occurrence. Reported incidences range from 5 to 20 per 100,000 persons. 1-4 However, this incidence is likely underestimated, as it fails to account for patients who may spontaneously recover or those who never seek medical attention. SSNHL is a subset of sudden hearing loss. As defined in the 2012 clinical practice guideline (CPG) of the American Academy of Otolaryngology Head and Neck Surgery Foundation (AAO-HNSF), sudden hearing loss is the rapid onset (72 hours) of subjective hearing impairment in 1 or both ears that meets the following audiologic criterion: a decrease 30 db that affects at least 3 consecutive frequencies as compared with previous audiograms or as related to the opposite ear s threshold. 5 SSNHL typically presents with sudden onset of fullness and tinnitus in 1 ear. Hearing loss may be the initial presenting symptom, but it may be masked by overwhelming 1 Department of Otolaryngology, San Antonio Military Medical Center, San Antonio, Texas, USA 2 Department of Otolaryngology, Walter Reed National Military Medical Center, Bethesda, Maryland, USA 3 Department of Defense Hearing Center of Excellence, San Antonio, Texas, USA This article was presented at the 2017 AAO-HNSF Annual Meeting & OTO Experience; September 10-13, 2017; Chicago, Illinois. The views expressed in this article are those of the authors and do not necessarily reflect the official policy or position of the Department of the Navy, Department of the Air Force, Department of the Army, Department of Defense, or the United States Government. The authors are military service members or employees of the US Government. This work was prepared as part of their official duties. Title 17 USC 105 provides that copyright protection under this title is not available for any work of the US Government. Title 17 USC 101 defines a US Government work as a work prepared by a military service member or employee of the US Government as part of that person s official duties. Corresponding Author: Charlotte K. Hughes, MD, MPH, Attn: MCHE-SDT, Department of Otolaryngology, San Antonio Military Medical Center, 3551 Roger Brooke Drive, JBSA Ft Sam Houston, TX 78234, USA. Charlotte.Kaplan.Hughes@gmail.com

2 Hughes et al 355 tinnitus. 1,2,4 In many cases, there are multiple clinical visits to primary care and emergency rooms without an accurate diagnosis, often resulting in unnecessary imaging studies and treatments. Additionally, hearing loss has devastating consequences on quality of life, with disruption in communication and negative effects on mental well-being, safety, and a patient s overall ability to effectively function in society. 6,7 Treating SSNHL is challenging as it is an idiopathic disease process in the majority of patients. In 71% of cases, an etiology is not identifiable. 2,4,8 With the dramatic effects of this pathophysiology, clinicians often employ multiple treatment options, including oral and transtympanic steroids, antiviral agents, vasoactive and hemodilution agents, vitamins/minerals, and/or hyperbaric oxygen therapy. 3,9 The AAO-HNSF CPG lists several treatment options that have been shown to be most effective if initiated as soon as possible after the onset of symptoms. 5 The AAO-HNSF 2012 CPG for SSNHL provides several evidence-based statements for diagnosis, treatment, and follow-up. Clinicians should first distinguish sensorineural hearing loss from conductive hearing loss clinically and/or via audiometry. Magnetic resonance imaging should be obtained to assess for retrocochlear pathology. The CPG recommends against computed tomography (CT) imaging and routine laboratory testing in the absence of other localizing symptoms. If there are no contraindications, the recommended initial therapy is oral prednisone (60 mg daily) for 10 to 14 days, followed by a taper. Intratympanic steroids can be offered as salvage therapy or when there are contraindications to oral steroids. Hyperbaric oxygen therapy is an option within 3 months of diagnosis. Other medications, including antivirals and antibiotics, are not recommended. 5 The Department of Defense (DoD) is uniquely positioned to review practice patterns across the Military Health System secondary to its universal electronic health record and its.9 million beneficiaries. 10 In the DoD, SSNHL is frequently managed by primary care, emergency medicine, and otolaryngology providers. The main purpose of this study was to evaluate provider compliance with the 2012 CPG for SSNHL and identify areas for improvement in the pathway from the primary care physician to the otolaryngologist. We hypothesized that while overall adherence to guidelines by otolaryngologists would be high, there would be areas for improvement primarily in regard to eliminating excessive laboratory testing and nonevidence-based therapies and facilitating a reduced referral time from primary care or the emergency department (ED) to the otolaryngologist. Methods This Institutional Review Board approved (FWH E) retrospective study utilized the DoD s electronic medical record, AHLTA, to identify and recruit patients who were diagnosed with sudden hearing loss (International Classification of Diseases, Ninth Revision diagnosis code 388.2) between March 1, 2012, and September 30, An AHLTA search revealed 1484 patients as having been diagnosed with, or evaluated for, sudden hearing loss across all DoD medical treatment facilities. This information was compiled and systematically reviewed, as described here, with all information maintained in a de-identified database for analysis. To be eligible for inclusion, patients had to be diagnosed with SSNHL in 1 or both ears, with audiologic evaluation demonstrating a decrease in hearing from previous evaluation or a comparative difference with a nonaffected ear of 30 db in at least 3 consecutive frequencies. Patients were excluded if their workup or treatment was conducted at a medical treatment facility where records were unavailable for review, if they failed to meet audiologic criteria for SSNHL, or if an alternative diagnosis to SSNHL was identified. Identified patient charts were systematically reviewed to encompass all hearing complaints within the study timeline. Demographic data were collected: patient age at onset, facility name of initial therapy, date of symptom onset, date of initial primary care/ed visit, date of initial audiology visit, date of initial otolaryngology visit, date of official diagnosis, number of ENT visits (ear, nose, and throat), and number of audiology visits. Symptom data collected included laterality of symptoms, current or prior tinnitus, dizziness, vertigo, prior hearing loss, ear trauma, otalgia, otorrhea, and aural fullness or pressure. Treatment data collected comprised laboratory tests and magnetic resonance imaging and/or CT evaluation; corticosteroid dose, route, taper, treatment duration, and timing of treatment; other pharmaceutical treatments; hyperbaric oxygen therapy, including dates, number of dives, and pressure of dives; and hearing rehabilitation type. Audiometric data included performance of tuning fork evaluation and audiogram. Data were analyzed in Microsoft Excel and Access and were based on descriptive analyses and correlation statistics between key variables. Results Of the 1484 patients diagnosed with or evaluated for sudden hearing loss, a random sample of 415 records was reviewed. This was determined to be an adequate sample based on a power analysis performed prior to initiation of the study. In this sample, 211 patients were excluded (Figure 1). Excluded patients were placed into 3 categories: insufficient data to diagnose (43%), failing to meet criteria for SSNHL (36%), and misdiagnosis (21%). The most common reason for insufficient data was failure to follow-up or outside referral to civilian practice with records unavailable. Of those failing to meet criteria for SSNHL, 81% demonstrated a loss of \30 db on \3 frequencies, while the remainder were found to have chronic sensorineural hearing loss. Under misdiagnosis, noise-induced trauma was the most common, followed by conductive hearing loss or eustachian tube dysfunction/serous otitis media. Demographic data are included in Table 1. Of the 204 remaining patients, 59% of

3 356 Otolaryngology Head and Neck Surgery 159(2) Number of Pa ents (n) Oral Prednisone Dose Figure 1. Patient inclusion flowchart. SSNHL, sudden sensorineural hearing loss Dose (mg/day) Figure 2. Oral steroid dosing. Table 1. Patient Demographics. Characteristic % 12 Intratympanic Steroid Dosing Sex Male 59 Female 41 Age, y Table 2. Time Interval from Onset of Symptoms to Initial Encounter with PCM/ED, ENT, and Audiology. Provider Average, d 75th Percentile, d Range, d PCM/ED Audiology ENT Abbreviations: ED, emergency department; ENT, ear, nose, and throat; PCM, primary care manager. them were male and 41% of them were female. Ages ranged from 4 to 92 years; the average was years. The average interval from onset of symptoms to evaluation by the primary care manager (PCM) or the ED was 4.86 days (95% CI, ), with a median of 2 and 75th percentile of 5 (Table 2). The time from onset to ENT evaluation was days (95% CI, ), with a median of 6 and a 75th percentile of 23. The time from onset to audiologic evaluation was days (95% CI, ), with a median of 6 and a 75th percentile of 18. The average patient received 2.59 audiograms (95% CI, Number of Pa ents (n) IT Steroid Administered (mg) Figure 3. Intratympanic (IT) steroid dosing ), with days (95% CI, ) between audiograms and with a total of 417 audiograms obtained for the 204 patients. The diagnostic workup for these patients was highly variable, with 150 of 204 (73.5%) receiving magnetic resonance imaging to evaluate for retrocochlear pathology (recommendation for), 28 (13.7%) receiving CT imaging of the head (strong recommendation against), and 50 (24.5%) having extra diagnostic laboratory work performed (strong recommendation against). Oral steroids were used among 137 of 204 (67.2%) patients, with 108 (78.80%) of them being treated with the recommended 60 mg of prednisone stated in the CPG (Figure 2). The length of oral steroid treatment varied from 2 to 30 days, with an average treatment of days (95% CI, ). The CPG recommends 10 to 14 days of oral steroid treatment. The most common length of therapy was 7 days. Oral steroids were prescribed by a primary care or ED provider for 38 of 137 (28%) patients. The remaining patients were treated with oral steroids by an otolaryngologist. Intratympanic steroids were utilized among 65 (31.9%) patients, with highly variable dose utilization (Figure 3). Two (3.08%) patients were treated with intratympanic steroids as initial therapy. Twenty-nine (44.6%) were treated with salvage therapy after oral steroids. The rest received intratympanic steroids in conjunction with oral steroids. A primary care or ED provider administered the intratympanic

4 Hughes et al 357 steroids in 8 (12.3%) of the 65 patients. The remaining intratympanic steroids were administered by an otolaryngologist. Only 8 (12.3%) of these patients were treated with an intratympanic dosage recommended by the guideline. One patient received a single dose of intramuscular steroids by a primary care provider. Hyperbaric oxygen therapy was utilized for only 2 (0.98%) patients. Additional medications, excluding those treating symptoms such as nausea or emesis, were prescribed 70 times across all patients. Discussion The DoD is uniquely positioned to evaluate adherence to CPGs on a nationwide basis given the robust electronic medical record system. Additionally, based on the ability to communicate with providers internationally, the DoD is uniquely situated to implement changes in practice to better align with the CPGs in treatment of SSNHL. Perhaps the greatest area for improvement identified involved prompt recognition and diagnosis of SSNHL, with rapid referral to ENT and audiology providers for management. Of those patients evaluated during this study, 75% presented to their PCM or the ED within 5 days of onset of symptoms, yet they were not seen by the ENT specialist or audiologist until an average of 15 and 14 days postonset, respectively. The factors leading to this delay in evaluation by the ENT specialist or audiologist are variable, with patient failure to follow up on referrals and initial misdiagnosis being among the more common reasons encountered. Regardless of the actual delay, SSNHL is considered 1 of the true otologic emergencies where prompt treatment is believed to result in increased return of function to the affected ear. 3,11 For a number of patient records, referrals were placed to ENT and/or audiology on the same day as presentation, with the delay in care occurring between referral placement and being seen by the next-level provider. This indicates a relative gap in patient education or in the use of the referral system for an emergent condition but more likely a combination of the 2 factors. Patients should be educated prior to leaving the PCM/ ED that this condition is urgent and warrants rapid evaluation and treatment, with minimal time to delay. Additionally, the PCM/ED provider should be aware of the urgent nature of this pathophysiology and should not only place a referral but also ensure prompt evaluation by the ENT/audiology provider and be comfortable to begin an appropriate course of oral steroid therapy if a delay must occur. Patient and primary provider educational materials are under development. The next significant gap in care involves the failure to recognize SSNHL as it initially presents. Of the total patients included, only 138 (68%) had tuning fork examinations documented. This is a well-described test to differentiate between sensorineural hearing loss and conductive hearing loss, which appears to have been overlooked and may aid in lowering errors in diagnosis, as a number of patients were misdiagnosed with eustachian tube dysfunction or an upper respiratory illness. 12 These examination techniques may minimize misdiagnosis and encourage more rapid referral, which may aid in the early capture of these patients. In regard to diagnosis and treatment of SSNHL, there remains room for improvement. The 2012 AAO-HNSF CPG recommends against (1) the use of medications in the treatment of SSNHL outside of oral or intratympanic steroids, (2) the use of CT imaging in diagnosis, and (3) obtaining routine diagnostic laboratory tests. 5 These recommendations are important to emphasize to all providers to minimize unnecessary imaging, laboratory testing, and medications, which increase health care costs and may increase patient risk. It is also vital to educate all providers that the recommended dose of oral prednisone is 60 mg daily for 10 to 14 days, with or without taper, with 3 intratympanic 24-mg/mL dexamethasone injections once weekly for salvage therapy or as initial therapy for those in which oral steroids are contraindicated This treatment algorithm will ensure prompt initiation of treatment to ensure maximal possible hearing salvage by maintaining a standard process. The DoD health care system is in the process of standardizing treatment dosing across all providers. CPGs are developed to reduce variation in practice and improve the quality of health care. However, previous studies showed that only about half of primary care providers actually use a CPG and \2% used an AAO-HNSF CPG. 17 Further training is needed to improve knowledge about the available CPGs. This additional training could be incorporated into didactic lectures at national conferences or within individual medical treatment facilities in the DoD. Additionally, the DoD s ability to communicate with providers at national and international levels can be leveraged to educate primary care and ED providers. This study shares the limitations of all retrospective large-database studies, including errors in coding and potential lack of documentation. Over a third of hearing loss cases were excluded because of insufficient data to diagnose SSNHL. This may have been due to poor record keeping or loss to follow-up, which is common in the DoD s inherently mobile population. The previous limitations also provide opportunities for education and process improvement for the health system. Conclusion SSNHL is an acute otologic emergency that warrants additional emphasis in the DoD to minimize delays to proper treatment in an attempt to minimize permanent hearing loss as a result of this disease process. Multiple gaps in care appear to exist, including patient education regarding the serious and potentially reversible nature of this disease, the ability to identify the process by PCM and ED providers, the need for rapid referral to ENT and audiology, and adherence to current evidence-based diagnostic and treatment recommendations. Author Contributions Charlotte K. Hughes, conception and design of the work; analysis agreement to be accountable; Jakob Fischer, acquisition, analysis

5 358 Otolaryngology Head and Neck Surgery 159(2) agreement to be accountable; Carlos R. Esquivel, conception and design of the work; acquisition, analysis and interpretation of data; drafting and revising; final approval; agreement to be accountable; Adrienne M. Laury, conception and design of the work; analysis agreement to be accountable. Disclosures Competing interests: None. Sponsorships: None. Funding source: None. References 1. Byl FM. Seventy-six cases of presumed sudden hearing loss occurring in 1973: prognosis and incidence. Laryngoscope. 1977;87: Chau JK, Lin JR, Atashband S, Irvine RA, Westerberg BD. Systematic review of the evidence for the etiology of adult sudden sensorineural hearing loss. Laryngoscope. 2010;120: Conlin AE, Parnes LS.Treatment of sudden sensorineural hearing loss: I. A systematic review. Arch Otolaryngol Head Neck Surg. 2007;133: Mattox DE, Simmons FB. Natural history of sudden sensorineural hearing loss. Ann Otol Rhinol Laryngol. 1977;86: Stachler RJ, Chandrasekhar SS, Archer SM, et al. Clinical practice guideline: sudden hearing loss. Otolaryngol Head Neck Surg. 2012;146(3):S1-S Carlsson PI, Hall M, Lind KJ, Danermark B. Quality of life, psychosocial consequences, and audiological rehabilitation after sudden sensorineural hearing loss. Int J Audiol. 2011;50: Wie OB, Pripp AH, Tvete O. Unilateral deafness in adults: effects on communication and social interaction. Ann Otol Rhinol Laryngol. 2010;119: Lin RJ, Krall R, Westerberg BD, Chadha NK, Chau JK. Systematic review and meta-analysis of the risk factors for sudden sensorineural hearing loss in adults. Laryngoscope. 2012;122: Labus J, Breil J, Stützer H, Michel O. Meta-analysis for the effect of medical therapy vs placebo on recovery of idiopathic sudden hearing loss. Laryngoscope. 2010;120: Military Health System. Beneficiary population stastics. Population-Statistics. Accessed September 22, Wei BP, Mubiru S, O Leary S. Steroids for idiopathic sudden sensorineural hearing loss. Cochrane Database Syst Rev. 2006; (1):CD Rauch SD. Clinical practice: idiopathic sudden sensorineural hearing loss. N Engl J Med. 2008;359: Han CS, Park JR, Boo SH. Clinical efficacy of initial intratympanic steroid treatment on sudden sensorineural hearing loss with diabetes. Otolaryngol Head Neck Surg. 2009;141: Haynes DS, O Malley M, Cohen S, Watford K, Labadie RF. Intratympanic dexamethasone for sudden sensorineural hearing loss after failure of systemic therapy. Laryngoscope. 2007;117: Kakehata S, Sasaki A, Oji K. Comparison of intratympanic and intravenous dexamethasone treatment on sudden sensorineural hearing loss with diabetes. Otol Neurotol. 2006;27: Powell-Tuck J, Bown RL, Lennard-Jones JE. A comparison of oral prednisolone given as single or multiple daily doses for active proctocolitis. Scand J Gastroenterol. 1978;13: Harvey M, Bowe S, Laury M. Clinical practice guidelines: whose practice are we guiding? Otolaryngol Head Neck Surg. 2016;155: