A software tool for pure‑tone audiometry

ObjectiveSelecting subjects for clinical trials on hearing loss therapies relies on the patient meeting the audiological inclusion criteria. In studies on the treatment of idiopathic sudden sensorineural hearing loss, the patient’s acute audiogram is usually compared with a previous audiogram, the audiogram of the non-affected ear, or a normal audiogram according to an ISO standard. Generally, many more patients are screened than actually fulfill the particular inclusion criteria. The inclusion criteria often require a calculation of pure-tone averages, selection of the most affected frequencies, and calculation of hearing loss differences.Materials and methodsA software tool was developed to simplify and accelerate this inclusion procedure for investigators to estimate the possible recruitment rate during the planning phase of a clinical trial and during the actual study. This tool is Microsoft Excel-based and easy to modify to meet the particular inclusion criteria of a specific clinical trial. The tool was retrospectively evaluated on 100 patients with acute hearing loss comparing the times for classifying automatically and manually. The study sample comprised 100 patients with idiopathic sudden sensorineural hearing loss.Results and conclusionThe age- and sex-related normative audiogram was calculated automatically by the tool and the hearing impairment was graded. The estimated recruitment rate of our sample was quickly calculated. Information about meeting the inclusion criteria was provided instantaneously. A significant reduction of 30 % in the time required for classifying (30 s per patient) was observed.

[1]  Gro Harlem Brundtland,et al.  Mental Health: New Understanding, New Hope , 2001 .

[2]  R. Mösges,et al.  Hemodilution Therapy With Hydroxyethyl Starch Solution (130/0.4) in Unilateral Idiopathic Sudden Sensorineural Hearing Loss: A Dose-Finding, Double-Blind, Placebo-Controlled, International Multicenter Trial With 210 Patients , 2007, Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology.

[3]  S. O'Leary,et al.  Steroids for idiopathic sudden sensorineural hearing loss. , 2013, The Cochrane database of systematic reviews.

[4]  K. Dietz,et al.  Outcomes research analysis of continuous intratympanic glucocorticoid delivery in patients with acute severe to profound hearing loss: Basis for planning randomized controlled trials , 2005, Acta oto-laryngologica.

[5]  D. Tucci,et al.  Treatment of Sudden Sensorineural Hearing Loss with Systemic Steroids and Valacyclovir , 2002, Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology.

[6]  S. Rauch,et al.  Oral Steroid Treatment of Sudden Sensorineural Hearing Loss: A Ten Year Retrospective Analysis , 2003, Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology.

[7]  R. Rosenfeld,et al.  Clinical Practice Guideline: Sudden Hearing Loss , 2011 .

[8]  H. Nickol,et al.  [Sudden deafness--on the age dependence of therapy results with reference to naftidrofuryl (Dusodril)]. , 1985, HNO.

[9]  K. Morawski,et al.  Efficacy and Safety of AM-111 in the Treatment of Acute Sensorineural Hearing Loss: A Double-Blind, Randomized, Placebo-Controlled Phase II Study , 2014, Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology.

[10]  A Martini,et al.  Achievements of the European Working Group on Genetics of Hearing Impairment. , 1999, International journal of pediatric otorhinolaryngology.

[11]  C. Meisner,et al.  Randomized, double blind, placebo controlled trial on the safety and efficacy of continuous intratympanic dexamethasone delivered via a round window catheter for severe to profound sudden idiopathic sensorineural hearing loss after failure of systemic therapy , 2009, The Laryngoscope.

[12]  C. Meisner,et al.  Comparison of Pure-Tone Audiometry Analysis in Sudden Hearing Loss Studies: Lack of Agreement for Different Outcome Measures , 2007, Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology.

[13]  J G Clark,et al.  Uses and abuses of hearing loss classification. , 1981, ASHA.

[14]  T. Nakashima,et al.  Evaluation of prostaglandin E1 therapy for sudden deafness , 1989, The Laryngoscope.

[15]  E. Hultcrantz,et al.  Corticosteroid Treatment of Idiopathic Sudden Sensorineural Hearing Loss: Randomized Triple-Blind Placebo-Controlled Trial , 2012, Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology.

[16]  D. Reda,et al.  Oral vs intratympanic corticosteroid therapy for idiopathic sudden sensorineural hearing loss: a randomized trial. , 2011, JAMA.

[17]  S. O'Leary,et al.  Steroids for idiopathic sudden sensorineural hearing loss. , 2006, The Cochrane database of systematic reviews.

[18]  K. Matsuura,et al.  Defibrinogenation Therapy for Idiopathic Sudden Sensorineural Hearing Loss in Comparison with High-dose Steroid Therapy , 2003, Acta oto-laryngologica.

[19]  David Goldenberg,et al.  Magnesium: A New Therapy for Idiopathic Sudden Sensorineural Hearing Loss , 2002, Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology.

[20]  D. Reda,et al.  Audiology in the Sudden Hearing Loss Clinical Trial , 2012, Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology.

[21]  R. Mösges,et al.  Effect of treatment with Ginkgo biloba extract EGb 761 (oral) on unilateral idiopathic sudden hearing loss in a prospective randomized double-blind study of 106 outpatients , 2001, European Archives of Oto-Rhino-Laryngology.