Friday September 20, 2019

First Self-Assisted Hearing Aid Approved by The FDA

The FDA reviewed data from clinical studies of 125 patients, showing that outcomes with self-fitting of the device are comparable on average to those with a professional fitting of the same device

0
//
FDA
An 85-year-old Nepalese man is seen fitted with a hearing aid, in Kathmandu, Nepal, April 12, 2017. VOA

The US Food and Drug Administration (FDA) on Friday allowed the marketing of a new hearing aid device that can amplify sounds for individuals 18 years or older with perceived mild to moderate hearing loss.

It is the first hearing aid approved by the agency that enables users to fit, programme and control the hearing aid on their own, without assistance from a health care provider, Xinhua news agency reported.

FDA
www.fdalawyersblog.com

Hearing loss, permanent or temporary, can be caused by aging, exposure to loud noises, certain medical conditions and other factors. Individuals with permanent hearing loss can use hearing aids to help them hear the speech and sounds.

The Bose Hearing Aid is a user-fitted wireless air conduction hearing aid, according to FDA.

Air conduction hearing aids can capture sound vibrations through one or more microphones and the signal is processed, amplified, and played back through an earphone placed in the ear canal.

FDA
A hearing aid (representative Image). Wikimedia

Patients can adjust the hearing aid through a mobile application on their phone. This technology enables users to fit the hearing aid settings themselves, in real-time and in real-world environments without the assistance of a health care professional.

Also Read: Eat Right Amount of Good Fat to Stay Healthy

The FDA reviewed data from clinical studies of 125 patients, showing that outcomes with self-fitting of the device are comparable on average to those with professional fitting of the same device with respect to the amount of amplification selected, speech in noise testing and overall benefit. (IANS)

Next Story

Physicians Happy While Traders in Shock on Ban on E-Cigarettes in India

With the Union Cabinet directing a blanket ban on e-cigarettes in the country, physicians welcomed the step while e-cigarette traders expressed shock and anger

0
e-cigarettes, health, union, ban, india
A man exhales while smoking an e-cigarette, Aug. 28, 2019. VOA

With the Union Cabinet directing a blanket ban on e-cigarettes in the country with complete suspension of their manufacturing, import, export, distribution and storage, physicians welcomed the step while e-cigarette traders expressed shock and anger over the decision.

“Although, e-cigarettes are little less lethal then the conventional cigarettes, we cannot shun away the fact that it contains harmful ingredients. These chemicals can potentially affect the lungs and overall health of the individual in the long run,” Rajesh Chawla, Senior Pulmonologist at Indraprastha Apollo Hospital in New Delhi, told IANS.

Industry body TRENDS which represents importers, distributors and marketers of ENDS, or Electronic Nicotine Delivery Systems in India, termed the decision to ban e-cigarettes “ironic and erratic”.

“This ban on e-cigarettes on the basis of ‘selective sourcing of scientific and medical opinion’ and without holding a single stakeholder meeting is nothing short of a complete murder of democratic norms,” said Praveen Rikhy, Convenor, TRENDS (Trade Representatives of ENDS).

“All our representations sharing best practices from other countries – 70 developed countries have allowed regulated sale of e-cigarettes, have been completely ignored. We will now initiate a formal campaign to help MPs understand the issue, clarify misapprehensions and misinformation spread by lobby groups and support the farmer groups who see the growth of the e-cigarette sector as a global market opportunity for nicotine,” Rikhy said.

e-cigarettes, health, union, ban, india
The Donald Trump administration on September 12 said that it plans to ban the sale of non-tobacco-flavoured e-cigarettes in the US following six deaths. Pixabay

While e-cigarettes have been marketed as a way for adults to quit conventional smoking, a recent outbreak of lung illness associated with use of vaping products in the US has raised concerns about the safety of these products.

The Donald Trump administration on September 12 said that it plans to ban the sale of non-tobacco-flavoured e-cigarettes in the US following six deaths linked to vaping.

Health authorities have documented a total of 450 cases involving e-cigarettes, according to the US Centers for Disease Control and Prevention (CDC), which issued a health warning against vaping.

ALSO READ: Girls Who Sleep Late At Night Are More Likely To Gain Weight

“I entirely support the idea of a ban on e-cigarettes; it is a step in the right direction,” Manoj Luthra, CEO, Jaypee Hospital in Noida, told IANS.

“E-cigarettes have been projected as a means to help people to quit smoking tobacco and also being non-polluting. However, these have their own health hazards and are addictive as well. These contain nicotine and other chemical vapours which will certainly have ill effects on the heart and lung and other organs as well,” he said. (IANS)