SNHL. Sudden SNHL. Steroids and Sudden Sensorineural Hearing Loss 11/11/2011

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1 Steroids and Sudden Sensorineural Hearing Loss David S. Haynes, MD, FACS The Otology Group of Vanderbilt The Department of Otolaryngology The Department Of Hearing and Speech Sciences Vanderbilt University Medical Center Intratympanic Dexamethasone for Sudden Sensorineural Hearing Loss After Failure of Systemic Therapy [Triological Society Papers: Candidate's Thesis] Haynes, David S. MD; O'Malley, Matthew MD; Cohen, Seth MD; Watford, Kenneth NP; Labadie, Robert F. MD, PhD From Vanderbilt University Medical Center/The Otology Group of Vanderbilt, Nashville, Tennessee, U.S.A. Editor's Note: This Manuscript was accepted for publication August 30, Send correspondence to David S. Haynes, MD, Associate Professor, Department of Otolaryngology/The Otology Group of Vanderbilt, st Avenue South, 7209 MCE South Tower, Nashville, TN 37232, U.S.A. Systemic Therapy SSNHL Intratympanic Therapy Hearing Preservation Surgery CI Intra cochlear Delivery Use of Steroids for all Otologic Surgery SNHL Definition: Idiopathic sudden sensorineural hearing loss(snhl) is defined as a decline in hearing over 3 days or less affecting 3 or more frequencies by 30 db or greater, with no identifiable etiology (Wilson 1980). (NIDCD definition) Wilson WR, Byl FM, Laird N. The efficacy of steroids in the treatment of idiopathic sudden hearing loss. A double-blind clinical study. Archives of Otolaryngology 1980;106:

2 Etiology of Disproportionate interest: (>2,000 articles written since 1966 or 1.3 articles per week) Reversible hearing loss Local expertise required Temporal relationship to negative outcome Patient frustration Etiology Examples Potential treatment (in addition to steroids) Viral infection HSV, Ramsey Hunt Antiviral agents Bacterial infection syphilis, lyme antibiotics Vascular occlusion Cerebrovasular accident, hypercoagulable state Aspirin, wafarin, heparin, Vasculitis Idiopathic Anti-inflammatory agents Meniere s disease Idiopathic Meniere s disease Diuretics, low sodium diet Labyrinthitis Viral, serous, bacterial Antiviral,antibiotics Meningitis Viral, bacterial, aseptic Antiviral,antibiotics Metabolic disorders Diabetes, hypo or hyperthyroidism Replacement therapy Hereditary disorders Usher s syndrome, Pendred s syndrome Genetics consult Hypoxia Cerebrovasular accident, hypotension, post-surgical/anestesia Neurology consult Ototoxic agents aminoglycosides hydration Malignant neoplasm Squamous cell carcinoma Surgery, radiation, chemotherapy Benign neoplasms Acoustic neuroma Surgery, radiation, observation Autoimmune hearing loss Idiopathic, Cogans Diuretics, rheumatology consult Cholesteatoma Fistula, inflammation Surgery, antibiotics Otosclerosis demineralization Surgery, fluoride, vitamin D,calcium, Cochlear implant Vertebrobasilar occlusive disorders Vertebrobasilar insufficency Surgery, Neurology consult Hypertension Idiopathic, adrenal disorder Anti-hypertensives Intracochlear membrane tears Idiopathic, meniere s disease diuretics Thromboembolic events Cerebrovasular accident, hypercoagulable state Aspirin, wafarin, heparin, Diagnostic tests Complete blood count ANA FTA-abs or MHA-TP Lyme titers ESR MRI with Gadolinium CT temporal bone HIV Western Blot Cholesterol Triglycerides Glucose Immunoglobulins IgA, IgG, IgM Audiogram ABR OAE PT/PTT/platelets creatinine Lymphoma, leukemia Autoimmune disorder syphilis Lyme disease inflammatory disorder, vasculitis etc Acoustic neuroma, glomus jugulare, stroke, abscess temporal lobe Mondini, enlarged vestibular aqueduct AIDS Immune mediated inner ear disease hypercholesterolemia hypertryglyceridemia diabetes Immune deficiency disorders standard standard standard Hypercoagulable state Renal disease Proposed therapies for sudden SNHL Steroids Antiviral agents Aspirin Coumadin Heparin Carbogen inhalation Anti-inflammatory agents Diuretics Hyperbaric oxygen Dexamethasone perfusion Methylprednisolone perfusion Steroid pump infusion Plasmaphoresis Cytoxan Methotrexate Dextran Histamine Calcium channel blockers Magnesium 2

3 Treatment Unknown etiology + Multiple proposed etiologies + limited time for treatment efficacy = shotgun therapy Treatment Old (1994) Vasodilator Regimen In patient Admission for 3 days IV steroids Carbogen inhalation Oral pavabid or ethatab ASA Dyazide SQ heparin Treatment New (2008) In patient Admission for 3 days IV steroids Carbogen inhalation Oral pavabid or ethatab ASA Dyazide SQ heparin Natural History: The natural history of untreated patients with sudden SNHL ranges from recovery rates of 31% to 65%, (1) (3) (4) (8) Wilson WR, Byl FM, Laird N. The efficacy of steroids in the treatment of idiopathic sudden hearing loss. A double-blind clinical study. Archives of Otolaryngology 1980;106: Chen CY, Halpin C, Rauch SD. Oral steroid treatment of sudden sensorineural hearing loss: a ten year retrospective analysis. Otology & Neurotology 2003;24: Cinamon U, Bendet E, Kronenberg J. Steroids, carbogen or placebo for sudden hearing loss: a prospective double-blind study. European Archives of Oto-Rhino-Laryngology 2001;258: Mattox DE, Simmons FB. Natural history of sudden sensorineural hearing loss. Annals of Otology, Rhinology & Laryngology 1977;86:

4 Treatment The range of hearing recovery reported in the literature in treated patients ranges from 35% to 89%. Treatment The range of hearing recovery reported in the literature in treated patients ranges from 35% to 89%. The natural history of untreated patients with sudden SNHL ranges from recovery rates of 31% to 65%, Slattery WH, Fisher LM, Iqbal Z, Liu N. Oral steroid regimens for idiopathic sudden sensorineural hearing loss. Otolaryngology - Head & Neck Surgery 2005;132:5-10..Moskowitz D, Lee KJ, Smith HW. Steroid use in idiopathic sudden sensorineural hearing losslaryngoscope 1984;94: Slattery WH, Fisher LM, Iqbal Z, Liu N. Oral steroid regimens for idiopathic sudden sensorineural hearing loss. Otolaryngology - Head & Neck Surgery 2005;132:5-10..Moskowitz D, Lee KJ, Smith HW. Steroid use in idiopathic sudden sensorineural hearing loss Laryngoscope1984;94: Treatment Why the wide range? Inconsistent definition of Wide range of time frames in which patients were treated Wide range of hearing losses Inconsistent definition of success or failure Medrol Dose Pack (Methylprednisolone) Day Medrol Prednisone 1 24 mg 30 mg 2 20 mg 25 mg 3 16 mg 20 mg 4 12 mg 15 mg 5 8 mg 10 mg 6 4mg 5 mg 105 mg 4

5 DepoMedrol 20mg/ml ; 40mg/ml ; 80mg/ml Methylprednisolone 25mg/ml ; 50mg/ml ; 100 mg/ml Prednisone equivalent Common Dose: mg Prednisone Tapered over 10D to 2 wks Generally 1ml injections given Sudden Visual Loss mg Methylprednisolone per day Informed consent Standard of Care Is there? What is it? Litigation Peptic ulcer Avascular necrosis of the hip Hyperglycemia Standard of Care? What the majority of physicians are doing in the area What the Thought Leaders in the area are doing. What the Academy Guidelines say Defined by the national literature. 5

6 Actions of Steroids on the Cochlea Both glucocorticoid and mineralocorticoid receptors are found in the inner ear. Decrease inflammation from labyrinthitis Improve cochlear blood flow Actions of Steroids on the Cochlea protect against cochlear ischemia, protect against noise induced hearing loss improve stria vascularis function and morphology Rarey KE, Luttge WG. Presence of type I and type II/IB receptors for adrenocorticosteroid hormones in the inner ear. Hearing Research 1989;41: Stockroos RJ, Albers FW, Schirm J. The etiology of idiopathic sudden sensorineural hearing loss. Experimental herpes simplex virus infection of the inner ear. American Journal of Otology 1998; 19(4): Nagura M, Iwasaki S, Wu R. et al. Effects of corticosteroid, contrast medium and ATP on focal microcirculatory disorders of the cochlea. European Journal of Pharmacology. 1999;366: Tabuchi K, Oikawa K, Uemaetomari I, Tsuji S, Wada T, Hara A. Glucocorticoids and dehydroepiandrosterone sulfate ameliorate ischemia-induced injury of the cochlea. Hearing Research 2003;180: Lamm K, Arnold W. The effect of prednisolone and non-steroidal anti-inflammatory agents on the normal and noise-damaged guinea pig inner ear. Hearing Research 1998;115: Trune DR, Wobig RJ, Kempton JB, Hefeneider SH. Steroid treatment improves cochlear function in the MRL.MpJ-Fas(lpr) autoimmune mouse. Hearing Research 1999;137: Actions of Steroids on the Cochlea Reduce hearing loss in in Meningitis (cochrane) Prevent loss of spiral ganglion neurons Modulate Na+/K+ in Endolymph Regulate transcriptional factors (AP-1)? Ototoxicity Brouwer MC. et al. Coricosteroids for Acute Bacterial Meningitis. Cochrane database Syst Rev 2010 Sept 8:9 CD Worsoe L, et al Systemic Steroids reduces long term hearing loss in experimental pneumococcal meningitis. Laryngoscope Sept 120(9) De Bosscher, et al The enterplay between the glucocorticoid receptor and nuclear factor-kappall or activator protein 1 :molecular mechanisms for gene repression. Endocr Rev 2003 Aug 24(4): Pondugula SR, et. Physiol Genomics 2006 Jan 12; 24(2) Spandow O, Anniko M, Hellström S. Hydrocortisone applied into the round window niche causes electrophysiological dysfunction of the inner ear. ORL J Otorhinolaryngol Relat Spec. 1989;51: Systemic Steroids In a double blind placebo controlled study, Wilson et al showed a statistically significant benefit with systemic steroids in recovery of hearing in patients with sudden SNHL. (1) Others demonstrating benefit of systemic steroids (3) (5) (6) (7) (11) Wilson WR, Byl FM, Laird N. The efficacy of steroids in the treatment of idiopathic sudden hearing loss. A double-blind clinical study. Archives of Otolaryngology 1980;106: Chen CY, Halpin C, Rauch SD. Oral steroid treatment of sudden sensorineural hearing loss: a ten year retrospective analysis. Otology & Neurotology 2003;24: Zadeh MH, Storper IS, Spitzer JB. Diagnosis and treatment of sudden-onset sensorineural hearing loss: a study of 51 patients. Otolaryngology - Head & Neck Surgery 2003;128: Fuse T, Aoyagi M, Funakubo T, Sakakibara A, Yoshida S. Short-term outcome and prognosis of acute low-tone sensorineural hearing loss by administration of steroid. Orl; Journal of Oto-Rhino-Laryngology & its Related Specialties 2002;64:6-10. Slattery WH, Fisher LM, Iqbal Z, Liu N. Oral steroid regimens for idiopathic sudden sensorineural hearing loss. Otolaryngology - Head & Neck Surgery 2005;132:5-10. Moskowitz D, Lee KJ, Smith HW. Steroid use in idiopathic sudden sensorineural hearing loss. Laryngoscope 1984;94:

7 Systemic Steroids Systemic steroids were shown to be of little to benefit in the treatment of sudden SNHL in several other studies. Systemic Steroids 2 RCT (Wilson/Cinamon) pooled for metaanalysis: no statistically significant difference between systemic steroids and placebo.. Byl FM, Jr. Sudden hearing loss: eight years' experience and suggested prognostic table. Laryngoscope 1984;94: Mattox DE, Simmons FB. Natural history of sudden sensorineural hearing loss. Annals of Otology, Rhinology & Laryngology 1977;86: Cinamon U, Bendet E, Kronenberg J. Steroids, carbogen or placebo for sudden hearing loss: a prospective double-blind study. European Archives of Oto-Rhino-Laryngology 2001;258: Conlin AE, Parnes LS. Treatment of Sudden Sensorinueral Hearing Loss. Arch Otolaryngol Head Neck Surg 2007;133: Wilson WR, Byl FM, Laird N. The efficacy of steroids in the treatment of idiopathic sudden hearing loss. A double-blind clinical study. Archives of Otolaryngology 1980;106: Cinamon U, Bendet E, Kronenberg J. Steroids, carbogen or placebo for sudden hearing loss: a prospective double-blind study. European Archives of Oto- Rhino-Laryngology 2001;258: Intratympanic Dexamethasone for Sudden Sensorineural Hearing Loss After Failure of Systemic Therapy [Triological Society Papers: Candidate's Thesis] Haynes, David S. MD; O'Malley, Matthew MD; Cohen, Seth MD; Watford, Kenneth NP; Labadie, Robert F. MD, PhD From Vanderbilt University Medical Center/The Otology Group of Vanderbilt, Nashville, Tennessee, U.S.A. Editor's Note: This Manuscript was accepted for publication August 30, Send correspondence to David S. Haynes, MD, Associate Professor, Department of Otolaryngology/The Otology Group of Vanderbilt, st Avenue South, 7209 MCE South Tower, Nashville, TN 37232, U.S.A. david.haynes@vanderbilt.edu Intratympanic therapy = Transtympanic therapy = Middle ear perfusion = Inner ear perfusion 7

8 Methods of IT Therapy Intratympanic Injection Microwick Microcatheter Intra-operative irrigation Hydrogel Nanoparticles Intratympanic Steroids 3 Physicians 3 separate injections 10 minutes apart, at the onset of therapy 3 separate injections 10 minutes apart, at the onset of therapy 1 injection at the completion of systemic therapy ( salvage therapy ) Never inject Intratympanic Steroids Intratympanic Steroids 3 Physicians 3 separate injections 10 minutes apart, at the onset of therapy 3 separate injections 10 minutes apart, at the onset of therapy 1 injection at the completion of systemic therapy ( salvage therapy ) Never inject ICD 9: Sudden Hearing loss CPT code: 69801, Labyrinthotomy/Infusion of Vestibuloactive Drugs 8

9 Hydrogel Methods of IT Therapy Dissolvable matrix (PLGA polymers) with Thermoreversable properties that releases medication in a controlled mechanism Dexamethasone, Brain-derived neurotrophic factor, insulin-like factor. Dexamethasone in perilymph [ng/ml] 100,000 10,000 1, IT Dexamethasone Otonomy mg/ml Time (days) Issues with IT Therapy Methods of Intra cochlear Delivery Electrode Array with egress pathways connected to an external pump Coating an electrode array with a biorelease polymer Osmotic Pump Delivery Reciprocating Perfusion System (McKenna, et al Boston) Microsystem technology Micro drug delivery system (power/reservoir/sensors/release mechanisms) Zero net fluid change Loss via Eustachian tube Absorption via Mucosa Vehicle? Healon? Viscosity? Round window contact Round Window Adhesions (30%) Concentration gradient Ototoxicity of vehicle/preservatives Delivery Time Cochlear Pharmacokinetics 9

10 Intratympanic therapy When? How? Which steroid? How often? Concentration? If? Itoh was the first to report on the use of intratympanic steroids for inner ear disease (for Meniere s disease) in The first report on the use of intratympanic steroids for sudden SNHL was by Silverstein in 1996 Itoh A, Sakata E. Treatment of vestibular disorders. Acta Otolaryngol Suppl. 1991;481: Silverstein H, Choo D, Rosenberg SI, Kuhn J, Seidman M, Stein I. Intratympanic steroid treatment of inner ear disease and tinnitus (preliminary report). Ear, Nose, & Throat Journal 1996;75: Timing Perform dexamethasone perfusion at the onset of systemic therapy Perform a dexamethasone perfusion only, eliminating systemic side effects from steroids while delivering steroids to the affected ear. Perform dexamethasone perfusion for patients failing to respond to medical therapy (salvage). Intratympanic steroids dosing schedule Single day Weekly intratympanic injections Multiple weeks with self-administered steroid drops Intratympanic injections given several times per week Implantable pump 10

11 Table 8. Summary of Studies published to date on Intratympanic Steroids for. Author Number of Steroid type Time Number of Study % improved Criteria for patients course injections Type improvement from hearing loss Silverstein, et al 8 Dex NA Up to3 times a salvage 25 % 10 db PTA 1996 (12) (various doses) week for % SDS weeks Parnes, * MP 40 mg/ml 2d Salvage 46% 5 nl thresholds (13) or weeks and 1 serviceable Dex primary hearing Kopke, et al. (17) 3 MP 62.5 >6wks Catheter for Salvage 0% 10 db PTA 2001 π mg/ml 14 days 15% SDS Kopke, et al. (17) 6 MP weeks or Catheter for Salvage 83% 10 db PTA 2001 mg/ml less 14 days 15% SDS Gianoli and Li (15) 23 Dex 25mg/mL 72 weeks 4 ( mL) Salvage 44% 10 db PTA 2001 MP 125mg/mL over %SDS days Chandrasekhar (14) 11π Dex 2-4 mg/ml 33 days 1-15 Salvage 73% Increase in SDS, 2001 decrease in PTA Lefebre and Staeker 6 MP 62.5mg/mL Approx 10 Catheter 8-10 Salvage 100% > 16 db (16) days days improvement in 2002 PTA Jackson (18) 19 Dex 4- NA Microwick NA 31% NA mg/mL 3 drops 3 times/day for 2-4 weeks Gouveris,(19) Dex 8 mg/ml 5.45 days 2.7 ave. Salvage Complete CR: within 10 db of a (1-7) recovery unaffected ear. Every 2 nd day (CR) 33.3% Partial: >10 db Partial 39.1% improvement No recovery NR: less than (NR) 28.6% 10dB improvement Gouveris, Dex 8 mg/ml 5.45 days 2.7 ave. Salvage CR 0% See a b (1-7) P 60% NR 40% Gouveris, 2003 c Ho, et al, (20) 2004 Lauterman, et al.,(23) 2005 Herr and Marzo(21) 2005 Battista (24) 2005 # Slattery, et al. (9) Dex 8 mg/ml 15 Dex 4mg/mL 13 MP 32mg/mL 17 Dex 10 mg/ml MP 62.5mg/m L 25 Dex 24mg/ml 20 MP 62.5mg/m L Haynes, et al 40 Dex 24 mg/ml 5.45 days 19.7 day averag e 2-3 days 6.3 weeks (2-20wks) 28 days Up to 3 months 40 days 2.7 ave. (1-7) 3 ( ml) over 3 wks 5 over 5 days Pump, microwick 8-14 days 4 over 14 days 4 injections over 2 weeks Single injection Salvag e Salvag e CR 0% P 31% NR 55.5% Initial 15.3% full recovery 15.3% partial 69% none Salvag e Initial salvag e salvag e See a 53% 30 db PTA Full, partial, none, recovery scale. No change from control. 53% 10 db PTA\ 20% SDS 8% full 12% partial Full: within 10 db baseline Partial: within 50 db baseline 55% 10 db PTA 12% SDS 26.7% 20dB PTA 20% SDS Gouveris, 2003 c 9 Dex 8 mg/ml 5.45 days 2.7 ave. (1-7) Salvage CR 0% P 31% NR 55.5% See a 13 studies on IT Steroids for Meniere s Disease 28 studies on IT Steroids for SSNHL For : Only 13 had controls (systemic steroids) Only one study was Double-blinded. 1/1/2000 to 7/30/ procedures (Intratympanic steroids) in 195 patients. Only 5 used the NIDCD definition of SSNHL 11

12 Table 2. Inclusion and Exclusion Criteria Sudden, unilateral SNHL of at least 30 db over 3 frequencies developing within 72 hours An audiogram was performed pre-treatment and at least 1 post therapy audiogram was performed Underwent a intratympanic injection with dexamthasone 24mg/ml at a single time period. No evidence of retrocochlear disease evident on MRI No prior history of otologic surgery No history of Meniere s disease, autoimmune hearing loss, radiation induced hearing loss or other potential etiology for SNHL No history of acoustic trauma or barotrauma No history of genetic SNHL or known inner ear anomaly No history of fluctuation of hearing prior to or following intratympanic therapy Failed systemic steroid trial, or did not receive steroid trial ( i.e. patient refused, diabetes) No evidence of acute otitis media or chronic otitis media on examination Failed systemic steroids Patient population 40 patients were available for study. 14 (35%) men and 26 (65 %) women. The mean age was 54.8, with a range from 17 to 84 years of age. The mean age for the women was 58 years and for the men 48 years. The overall recovery rate for men was 35.7% and for women was 23%.( p=0.5 Fisher Exact test) Patient population All treated with systemic therapy All failed systemic therapy Range from onset of symptoms to injection ranged from 5 days to 310 days (mean 40.1 days) Dexamethasone Solution for Otic Injection (single injection) Ingredients: Dexamethasone Sodium Phosphate, Powder, U.S.P. 120 mg Starting Materials: Sterile empty 10 ml vials, dry only, for example, Abbott brand Sterilized stainless steel spatula, vial stopper decapper and crimper, electronic scales with printer, serum bottle aluminum seals 20 mm Compounding: 1. Use scale in Chemo preparation area Don appropriate compounding attire, including gown, mask, hair cover, and gloves. No other personnel should be in work area when weighing powder. Remove stoppers from 10 ml vials. Place vial on scale and tare weight. With stainless steal spatula, add 120mg of powder to each vial. Replace stoppers and add new aluminum seals. Crimp tightly and check seal. Label appropriately. Dispensing Directions 1. Dilute each vial with 5 ml of Preservative Free Sterile sterile saline for a final concentration 24 mg / ml Filter before dipensing with 0.22 micron filter, such as Millex GS filter. Expiration date of diluted product 24 hours. References : Requested for use by physicians Expiration Date: Vials of powder 6 month expiration date, due to U.S.P. standards Assign 24 hour expiration date on diluted product Storage: Refrigerate, powder storage directions from manufacturer Auxiliary Labels: For External/Otic Irrigation Use Only Sample Labels: Dexamethasone Sodium Phosphate, U.S.P. For Otic Irrigation Use Only Lot # M1 date Must be filtered with 0.22 micron filter before use NOT FOR INJECTION NOT FOR INJECTION 12

13 Results RESULTS: Overall 40% (n=16) showed improvement in PTA or SDS. For those 37.5% (n=15) showing an improvement in PTA, the mean gain was 15 db. For the 37.5% (n=15) showing an improvement in SDS, the mean gain was 31.9% (range 8-88). Using the criteria of 20 db improvement in PTA or 20% improvement in SDS for success, a 27.5% (n=11) improvement was noted. For these 27.5% who had an improvement, an average improvement in PTA of 16.9 db (range 0-42dB) average improvement in SDS of 38.9% (range 8-88%) was noted. Overall recovery: 27.5% (20dB, 20%discrimination) 39% of patients recovering 20 db or 20% SDS (if treated within six weeks) (between 2 and 6 weeks after onset of symptoms), 26% improved by 20dB or 20% SDS Seven patients (17.5%) showed worse PTA, with a mean decrease of 3.8 db (range 2-7dB). Five patients (12.5%) showed worse SDS after injection, with a mean decrease of 16% (range 8-28%). Table 9. Comparison of recovery rates in sudden SNHL treated with intratympanic steroids. Author % improved Criteria for improvement Current study with applied criteria Percent increase in SDS Recovery in SDS as a function of time from onset of symptoms to injection (n=11) Days from onset of symptoms to injection Silverstein, et al 1996 (12) Parnes, 1999 Kopke, et al. (17) 2001 (>6 wks) π Kopke, et al. (17) 2001 (<6 wks) Chandrasekhar (14) 2001 Gianoli and Li (15) % 10 db PTA 15% SDS 32.5% 46% 5 nl thresholds 1 serviceable hearing 0% 10 db PTA 15% SDS 83% 10 db PTA 15% SDS 73% Increase in SDS, decrease in PTA 44% 10 db PTA 10 %SDS 40% 57% if including only patients treated within 6wks) 0% 35% overall 50% if including only patients treated within 6wks) 40% 40% Lefebre and Staeker (16) % > 16 db improvement in PTA 12.5% (overall) 50% if treated within 10 days 13

14 Table 9. Comparison of recovery rates in sudden SNHL treated with intratympanic steroids. Gouveris (19) 2003 Complete recovery (CR): 33.3% Partial: 39% No recovery: (NR) 28.6% CR: within 10 db of unaffected ear. NR: less than 10 db improvement CR 2.5% Partial 15% NR 82.5% Jackson, 2002 (18) 31% Positive response 40% Ho, et al, 2004 (20) 53% 30 db PTA 7.5% (10.3% if only those treated within 50 days) Success range using criteria from previous articles on IT steroids for SSNHL (6 weeks or less) 12% - 60% Herr and Marzo (21) % 10 db PTA\ 20% SDS 32.5 % (33.3% if only those treated within 20 wks) Battista (24) 2005# 8% full 12% partial Full within 10 db baseline Partial within 50 db baseline 2.5% full 10% partial overall Slattery et al (9) % 10 db PTA 12% SDS 40% (42.1%if only those treated within 3 months) Intratympanic Steroids Conclusions Dramatic recovery or late recovery was uncommon with IT steroids after idiopathic SSNHL Literature supports various definitions of success for Sudden SNHL Multiple papers providing mechanism of benefit for Steroids in cochlea Clinical benefit hard to prove Clinical use of systemic and intratympanic steroids will continue Emerging Technologies for drug delivery Intratympanic Steroids for Sudden Sensorineural Hearing Loss: A Systematic Review 2011 Otolaryngology Head and Neck Surgery Samuel A. Spear, MD1, and Seth R. Schwartz, MD, MPH2 Intratympanic steroid treatment as primary treatment for sudden sensorineural hearing loss appears equivalent to treatment with high-dose oral prednisone therapy. As salvage therapy, intratympanic steroids offer the potential for some degree of additional hearing recovery, although it remains uncertain if this improvement is clinically significant and what percentage of patients is likely to show benefit. 14

15 Rehabilitation AAO-HNS Position on 8. Initial corticosteroids. Clinicians may offer corticosteroids as initial therapy to patients with ISSNHL. It is not clear that steroids may help ISSNHL patients, but a small possibility of hearing improvement through steroid use may be worth pursuing, 11. Salvage therapy. Clinicians should offer intratympanic steroid perfusion when patients have incomplete recovery from ISSNHL after initial therapy.. Current: Baha FDA approved for Unilateral SNHL Choose patients carefully Contralateral stimulation Poor localization Future: Cochlear Implant Not FDA approved for unilateral SNHL Utilizes affected ear Binaural hearing Localization Rehabilitation What constitutes an adequate steroid trial? Medrol dose pack 7-10 days of prednisone? 1 month trial of prednisone? Therapy 15

16 WHAT IF? Severe diabetes? Diet controlled Oral agents Insulin dependent WHAT IF? Patient presents 4 weeks after the onset of hearing loss? 6 weeks? WHAT IF? The sudden loss occurred in an only hearing ear? Treat differently? WHAT IF? You see the patient at 2 weeks out for a second opinion and the patient was treated only with a Medrol dose pack? 16

17 Litigation? For delay in delivering therapy? Are steroids standard of care? For complications of steroid therapy AVN Hyperglycemic event Gastric complications International Cochlear Implants in Children 2014 Nashville, Tennessee For failure to offer IT steroids? For complications of IT steroids? 17