Release: Embargoed until September 26
Contact: Ken Satterfield
(in New Orleans: 9/23-29 at 504-670-5409) [email protected]

STEROIDS ADMINISTERED DIRECTLY INTO THE MIDDLE EAR PROVES EFFECTIVE IN TREATING SUDDEN HEARING LOSS

A safe, surgical procedure offers hope for the hearing impaired who have failed to respond to oral steroids

New Orleans -- The standard medical regimen for sudden onset sensorineural hearing loss usually involves systemic steroid therapy. Unfortunately, some patients do not respond successfully or are poorly tolerant of systemic steroids. Transtympanic administration of steroids has been suggested as an alternative to systemic therapy. This study determines whether transtympanic steroid administration may be an effective treatment for sudden hearing loss in patients who have failed systemic steroid treatment or who were not candidates for systemic steroids.

The authors of the study, "Transtympanic Steroids for Treatment of Sudden Hearing Loss," are Gerard J. Gianoli, MD, Associate Professor of Otolayrngology--Head and Neck Surgery, Tulane University, New Orleans, LA, and John C. Li, MD, from Jupiter, FL.

The results were presented before the American Academy of Otolaryngology--Head and Neck Surgery Foundation Annual Meeting and Oto Expo being held September 26-29, at the Ernest N. Morial Convention Center in New Orleans, LA. At the gathering, the Academy's 11,000 members will have the opportunity to hear the latest research in the diagnosis and treatment of disorders of the ear, nose, throat, and related structures of the head and neck.

Methodology:

A prospective study was designed to evaluate the hearing outcomes for sudden hearing loss in patients treated with transtympanic steroids. Patients who received transtympanic steroids either failed, or were not able to tolerate oral steroids. Hearing was assessed immediately prior to therapy and within 1-2 weeks after therapy

Transtympanic steroids were administered through a ventilation tube placed under local anesthesia. The steroids were instilled in the middle ear with the patient's head tilted 45 degrees. The instillation was performed so that the tip of the needle extended through the ventilation tube and into the middle ear. This was done in order to allow air to escape and prevent bubble formation. The steroids were allowed to perfuse the middle ear for 30 minutes. Steroid administration was performed on four separate occasions over the course of 10-14 days.

Data collected included age, gender, and time for treatment. Audiometric data collected included pre and post-treatment pure tone averages, speech reception thresholds, and speech discrimination. A change of greater than or equal to 10 dB in the pure tone average or speech reception threshold was considered significant. A change of greater than or equal to 10% in speech discrimination was considered significant.

Results:

Twenty-three patients were enrolled in the study. Of these, 22 had unsuccessful outcomes in prior steroid therapy, and one had not been able to tolerate steroid therapy. The average age of the patients was 63 years with a range of 34 to 83. There were 12 men and 11 women. Time from onset to therapy averaged 72 weeks and ranged from zero to 520 weeks. Methylpredisolone was perfused, or passed through, in 12 patients and dexamethasone in 11 patients. There was one complication -- otitis media in one patient that responded to oral and topical antibiotics. The researchers found:

Overall, pure tone average improvement was documented in 10 patients (44 percent) after transtympanic steroid administration. The average change in pure tone average for those with significant improvement was 15.2dB. Twelve patients (52 percent) had no significant improvement in pure tone average. The one patient (4 percent) who had post-perfusion otitis media had a drop in the pure tone average of 10dB -- the pure tone average returned to the baseline after the infection cleared.

The speech reception threshold improved in 11 patients (48 percent). The average improvement among these patients was 15dB. Twelve patients (52 percent ) noted no change, and there were no patients with a significant decline in the speech reception threshold. Speech discrimination was improved in eight patients (35%) with an average improvement of 21 percent . Fourteen patients (61 percent) had no change in speech discrimination, and one patient (4 percent) had a decline in speech discrimination of 16 percent.

Patients were stratified by time to therapy before or after six weeks from the onset of hearing loss. Seven patients received therapy before six weeks, and 16 received therapy after six weeks from the onset. No statistically significant differences were noted for pure tone average, speech reception threshold, or speech discrimination for therapy instituted before or after six weeks.

Patients were also stratified by age. There were 10 patients less than 60 years of age and 13 older than 60. Comparing the patients more than 60 to those younger than 60, there was no statistically significant difference for pure tone average, speech reception threshold, or speech discrimination. More favorable results were noted for the younger patients when comparing pure tone average results (50 percent vs. 30 percent).

There were 12 patients treated with methylprednisolone and 11 treated with dexamethasone. Although there was no statistically significant difference in these groups, more than twice as many of the methylprednisolone patients (58 percent) had improved pure tone averages compared to the dexamethasone patients (27 percent), and similar trends were noted for a speech reception threshold (58 percent vs. 36 percent) and speech discrimination scores (42 percent vs. 27 percent).

No statistically significant differences were noted for outcomes comparing men and women. However, men had more favorable outcomes twice as often as the women for pure tone average (58 percent vs. 27 percent), speech reception threshold (67 percent vs. 27 percent), and speech discrimination (42 percent vs. 27 percent).

Conclusion:

The study demonstrated a 44 percent response rate in sudden hearing loss patients that would have otherwise been considered treatment failures from systemic steroid therapy. No statistical differences were noted for comparison groups, but there was a trend for better results in younger patients, men and those treated with methylprednisolone. Transtympanic steroid therapy may be an alternative for treatment for patients with sudden hearing loss who have failed or cannot tolerate systemic steroid therapy.

- end -

Editor's Note: For a copy of this study or an interview with Dr. Gianoli , contact Ken Satterfield at 703-519-1563
(through 9-21); 9/23-29, call the Annual Meeting Newsroom at 504-670-5409.