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Sudden hearing loss affects 5-20 individuals per 100,000, which equates to about 4,000 new cases each year in the U.S.
ISSHL is the newest indication approved by the Undersea and Hyperbaric Medical Society's Hyperbaric Oxygen Therapy Committee (approved on October 8, 2011). A review of the literature reveals more than 100 publications evaluating the use of HBOT for the treatment of ISSHL, including eight randomized controlled trials (RCTs).
HBOT is also indicated for use as an adjunctive therapy in the treatment of a number of conditions.
Click here to view my blog containing a comprehensive list of all of the approved indications for HBOT. About the AuthorLindsay (Prussman) Andronaco is board certified in wound care by the Wound Ostomy Continence Nursing Certification Board. Lindsay is board certified in wound care by the Wound Ostomy Continence Nursing Certification Board. The views and opinions expressed in this blog are solely those of the author, and do not represent the views of WoundSource, Kestrel Health Information, Inc., its affiliates, or subsidiary companies. Important Notice: The contents of the website such as text, graphics, images, and other materials contained on the website ("Content") are for informational purposes only. 21.Xenellis J, Papadimitriou N, Nikolopoulos T, Maragoudakis P, Segas J, Tzagaroulakis A, Ferekidis E. Selecting subjects for clinical trials on hearing loss therapies relies on the patient meeting the audiological inclusion criteria. A 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. The age- and sex-related normative audiogram was calculated automatically by the tool and the hearing impairment was graded.
Primary outcomes in clinical trials on treatments of ISSHL are mainly based on average pure-tone thresholds [12, 14, 16, 18, 22]. A Microsoft Excel file was developed to provide an easy-to-use tool for classifying patients to be included in clinical trials. The hearing thresholds of the acute and the baseline audiograms are entered in the a€?audiogramsa€? table. Grading of hearing impairment is displayed for every acute or baseline audiogram, assuming it is the better ear.
The a€?recommendation on inclusiona€? is based on the inclusion parameters, separately for every baseline audiogram. The software tool can simplify the screening of audiograms to compare with inclusion criteria of clinical trials. AcknowledgmentsThis work was supported by the University Hospital and the Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.
References1.Burschka MA, Hassan HA, Reineke T, van Bebber L, Caird DM, Mosges R (2001) 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.
Idiopathic Sudden Sensorineural Hearing Loss, or ISSHL, is spontaneous hearing loss in one or both ears with no apparent or known cause. ISSHL appears to be characterized by hypoxia in the perilymph and therefore the scala tympani and the organ of Corti. HBOT is also the only reviewed ISSHL treatment found by the Cochrane Review to be effective.


This is a significant gain that can markedly improve a patient's quality of life, both clinically and functionally. The Content is not intended to be a substitute for professional medical advice, diagnosis, or treatment.
Systemic steroids and intratympanic steroids perfusion as an initial therapy for idiopathic sudden sensorineural hearing loss, a comparative study. Effectiveness of intratympanic dexamethasone injection in sudden-deafness patients as salvage treatment. Corticosteroid pharmacokinetics in the inner ear fluids: an animal study followed by clinical application.
Intratympanic dexamethasone for sudden sensorineural hearing loss: clinical and laboratory evaluation.
Intratympanic dexamethasone as initial therapy for idiopathic sudden sensorineural hearing loss: clinical evaluation and laboratory investigation.
Distribution of Na, K-ATPase is normal in the inner ear of a mouse with a null mutation of the glucocorticoid receptor.
Intratympanic immunosuppressives for prevention of immune-mediated sensorineural hearing loss.
Intratympanic steroid treatment in idiopathic sudden sensorineural hearing loss: a control study.
Usefulness of high doses of glucocorticoids and hyperbaric oxygen therapy in sudden sensorineural hearing loss treatment. In studies on the treatment of idiopathic sudden sensorineural hearing loss, the patienta€™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.
This tool is Microsoft Excel-based and easy to modify to meet the particular inclusion criteria of a specific clinical trial. Owing to the natural course of the disease and the biometrical aspects of the study design, the inclusion and outcome parameters are very heterogeneous [2, 6, 14].
When studying the effects of an intervention, it is meaningful to look at those parameters or frequencies that have been affected by the diseases. This tool allows for the comparison of audiograms with the ISO 7029 norm [7] and automatically calculates the severity of absolute and incident-related hearing loss. If both the severity of hearing loss and the hearing loss of three consecutive frequencies meet the predefined inclusion criteria, a positive decision is recommended and the color of the fields change from red to green.
The rationale for the use of hyperbaric oxygen therapy (HBOT) and corticosteroids to treat ISSHL is based on the high metabolism and poor vascularity of the cochlea. The best and most consistent results are obtained when HBOT is initiated within two weeks of symptom onset and combined with corticosteroid treatment.
Although starting HBOT within two weeks is preferred, The American Academy of Otolaryngology - Head and Neck Surgery guidelines recommend that HBOT be considered as a treatment up to three months from symptoms onset. Generally, many more patients are screened than actually fulfill the particular inclusion criteria.
The tool was retrospectively evaluated on 100 patients with acute hearing loss comparing the times for classifying automatically and manually. In addition, when planning clinical trials, it is necessary to make accurate recruitment estimates based on retrospective data. An average of all frequencies in a certain predefined region underestimates the effect of an intervention.


If enough valid data points have been entered, the color of the a€?data checka€? field turns from red to green. The most important parameters can quickly be changed and the tool is easily adaptable to a variety of studies.
The cochlea and the structures within it, particularly the stria vascularis and the organ of Corti, require a high oxygen supply. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or product usage. The inclusion criteria often require a calculation of pure-tone averages, selection of the most affected frequencies, and calculation of hearing loss differences. A significant reduction of 30a€‰% in the time required for classifying (30 s per patient) was observed. Therefore, several authors used the three most affected frequencies as primary or secondary outcome measures for evaluation of the treatment [1, 8, 12, 19].
The color of the 4PTA fields changes to green if the value is higher than the predefined minimum severity of current hearing loss. Retrospectively, audiograms of 100 patients with ISSHL were classified to meet the respective inclusion criteria and the time needed for manual classification was compared with automatic classification using the tool. Corticosteroids improve ISSHL by decreasing inflammation and edema, while HBOT increases tissue oxygenation and improves outcomes. In these cases, the three most affected consecutive frequencies are selected and the hearing loss is calculated at the screening visit relative to a baseline value.
The a€?patient demographica€? table contains the optional ID, age, and sex of the patients. As the affected ear may often be the worse hearing ear, the grading calculation is for qualitative information only. The user can modify the preset inclusion criteria for the respective clinical trial in the a€?inclusion parametersa€? table. We could quickly measure the estimated recruitment rate (based only on audiological inclusion criteria).
The time reduction necessary for classifying audiograms using the tool was significant and relevant. However, since such an audiogram is often not available, studies have also used the unaffected contralateral ear for comparison [1, 5, 11, 16, 20, 21] or age- and sex-related normative hearing [4, 9].
The a€?minimum hearing levela€? difference is calculated as the maximum difference between the mean hearing thresholds of three consecutive frequencies of the acute audiogram and the respective baseline. If the respective inclusion criteria do not have to be used, the value has to be set to zero. The estimated recruitment rate is expected to be more easily available or even more reliable than if the number of eligible patients is estimated on a more subjective basis.
Thus, the final planning of the number of centers in a proposed trial might be improved.



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