This information is interesting to the US audience of the OAE Portal. We have been informed from Mr. Gabrielle Gonzalez about a series of Social Security benefits regarding hearing disabilities. The links provided are placed in the section "Information for Families".
The "information for Families" material has been updated with 4 Successful Cochlear Implant stories, which were presented in the Second Conference on Cochlear Implants and Music (July 14th 2016, Warsaw Poland).
In the November issue of the ECHO initiative Probes & Tips, there is a presentation of a simple EXCEL tool , which can track and provide basic information on hearing screening activities. Although the information has to be inserted manually, the EXCEL solution is a good backup strategy for hearing screening sites with low birth rates. It can be also a good solution for displaying monthly screening activities. The EXCEL spreadsheet (2016 version ) and the guide of how to use it can be downloaded from the ECHO website.
Usually we do not report in the Portal inner ear Pharmacology news, but this one is different. The news refer to clinical data treating patients with tinnitus after an occurrence of otitis media. This scenario implies a peripheral tinnitus generation and as such it is of great interest, since the genesis mechanisms of tinnitus are multiple and usually more central-Auditory System oriented.
From the web site of Auris Medical Holding :
Auris Medical Holding AG (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology, today announced additional clinical data as well as updates to its development plan for KeyzilenTM (AM-101) in acute inner ear tinnitus.
Based on insights from the recently completed TACTT2 trial, the Company is submitting a protocol amendment to regulatory agencies in Europe for TACTT3, the ongoing second Phase 3 clinical trial. In the amended trial protocol, the change in Tinnitus Functional Index (TFI) score will be elevated from a key secondary endpoint to an alternate primary efficacy endpoint. Certain patient subgroups will be included in confirmatory statistical testing, and the trial size will be increased to enhance statistical sensitivity to the effects of treatment. Top-line results from the expanded TACTT3 trial are now expected in early 2018. The outcomes from TACTT2 and the regulatory path forward will be reviewed with the US Food and Drug Administration in early December 2016.
TACTT2 was a randomized, double-blind, placebo-controlled trial conducted primarily in North America, enrolling 343 patients suffering from acute inner ear tinnitus following traumatic cochlear injury or otitis media. As previously announced, the trial failed to meet its two co-primary endpoints: the change in subjective tinnitus loudness (tinnitus loudness question; TLQ) and the change in tinnitus burden measured by the TFI from baseline to Day 84 over placebo. However, the TACTT2 trial data show treatment effects on TFI in favor of KeyzilenTM for specific subgroups. In the pre-specified subgroup of patients suffering from tinnitus following otitis media, treatment with KeyzilenTM resulted in a clinically meaningful and statistically significant reduction of 14.8 points in the TFI from baseline, as compared to 6.2 points for placebo (p=0.048). A reduction of 13 points was defined as clinically meaningful by the developers of the TFI. A trend for improvement was also observed in active-treated patients who suffered from severe or extreme tinnitus at baseline with a clinically meaningful reduction in TFI of 15.5 points as compared to 11.5 points in the placebo group (p=0.238). Unexpectedly, the TLQ showed a lower sensitivity to change than the TFI, which the Company believes to be related to the frequent (daily) rating of tinnitus loudness over an extended period of time.
You can access the rest of the article in the Auris Medical Holding website:
The section on White papers , subsection of Clinical applications was updated with a contribution from Dr. Maria Riga titled "Subjective tinnitus and contralateral suppression of otoacoustic emissions; an attempt to validate cut-off points with clinically useful positive or negative predictive value in normal hearing adults". Dr. Riga is currently an Assistant Professor of Otorhinolaryngology at Democritus University of Thrace, in Alexandroupolis, Greece.