By Daniel Fink, MD, Chair, The Quiet Coalition

For many years, a body of research has shown that chemicals with antioxidant properties might prevent or reduce hearing loss after noise exposure. In animals, noise exposure reduces levels of a chemical called glutathione peroxidase 1 (a naturally occurring enzyme). A recent report in the British journal The Lancet looks at how a similar chemical, ebselen, works in helping to reduce “both temporary and permanent noise-induced hearing loss in preclinical studies.”

It appears to work quite well.

Of course, we at The Quiet Coalition think it’s better just to avoid loud noise exposure, which is 100% safe and effective at preventing hearing loss. That said, the experimental protocol raises interesting questions about research ethics. Namely, the study tested the efficacy of different doses of ebselen after the subjects, healthy adults aged 18–31 years, were exposed to loud sound. The measure of ebselen’s success was the prevention of a phenomenon called temporary threshold shift (TTS), more completely noise-induced temporary threshold shift (NITTS). This audiometric measure has been used for decades to measure the impact of noise on humans.

Unfortunately, recent research, beginning with a 2009 report and updated last year describes a phenomenon called “hidden hearing loss,” a synaptopathy (injury to the synapses in the cochlea) caused by noise exposure. Hidden hearing loss is called that because it is not detected by standard audiometric techniques. Hidden hearing loss is the likely cause of being unable to follow one conversation among many in a noisy environment, or having a normal or near-normal audiogram but still having difficulty understanding speech.

Many experts think that there is no temporary auditory damage. That is, TTS is a real phenomenon but the use of the word “temporary” is misleading because if TTS occurs then it is likely that permanent auditory damage has also occurred.

In this study, healthy young adults were exposed to noise levels loud enough and long enough to cause TTS, likely indicating permanent auditory damage. Some of the subjects were given large enough doses of the experimental drug ebselen to prevent TTS from occurring, but whether the drug would or wouldn’t work, and at what dosage, wasn’t known when the study began. Simply put, the study exposed all subjects to the threat of auditory damage, and most likely caused auditory damage in the subjects who received the placebo or didn’t get a high enough dose of the experimental drug.

All research protocols in the U.S. must pass review by an Institutional Review Board (IRB) which must make certain that steps are taken to prevent harm to research subjects.. Under the Helsinki Declaration of the World Medical Association, and in the United States under what is called the federal “Common Rule” (45 CFR §46 et seq.), human subjects must be protected. If there is a risk of permanent auditory damage when the phenomenon of TTS is observed–and Drs. Liberman and colleagues certainly think that temporary auditory changes denote permanent auditory damage–we think the IRB should have done more to protect the subjects from any possibility of harm.

How could a study that exposes young people to noise levels loud and long enough to cause TTS pass IRB review? We hope the federal Office for Human Research Protections will let us know.

 

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