What are the clinical trial results for the Esteem?

Posted by Envoy Medical Staff Member on November 9, 2018

Closeup of examining ear with an otoscope

What are the clinical trial results for the Esteem?

In order to gain license from the Food and Drug Administration (FDA) to commercially market and sell the Esteem, Envoy Medical had to go through what is called the "premarket approval" process. The premarket approval requirements are stringent, resource intensive, and highly regulated. It is incredibly difficult to get a new medical device approved through the FDA's premarket approval process (especially a medical device that is a first-of-its-kind), but, at the end of the day, consumers can rest assured that once the product's PMA application has been approved the product has met the FDA's high standards of safety and effectiveness.

One of the biggest requirements of a premarket approval application, is a closely monitored clinical trial. Envoy Medical designed the Esteem's clinical trial in close collaboration with the FDA. The overall goal of the trial was to demonstrate both the safety and the effective benefit of the Esteem to those with sensorineural hearing loss. In total, 57 patients were implanted, and then closely monitored. The data reviewed by the FDA and its panel of experts in order to grant Esteem premarket approval were data collected through 10 months on all 57 implanted patients. In addition, the patients were followed for another 5 years to demonstrate long-term safety and effectiveness.

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Topics: Esteem, hearing loss, clinical results

Increasing Costs of Untreated Hearing Loss

Posted by Envoy Medical Staff Member on November 2, 2018

Emotional and Psychological Costs of Untreated Hearing Loss

Many people assume the main effect of hearing loss is difficulty perceiving spoken communication, environmental sounds and music. But there are secondary psychological and emotional effects to consider, as well. Individuals with hearing loss commonly report anger, denial, isolation, social withdrawal, fatigue and depression. Let’s take a closer look at some of those effects.

  1. Feelings of isolation. Persons with hearing impairment may withdraw or distance themselves socially because they find it too difficult to hear and take part in conversation, creating a sense of isolation. Or they may feel embarrassed that they need to frequently ask for repetition. This withdrawal may in turn cause depression, frustration, annoyance or sadness in their family members and other communication partners.
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Topics: hearing loss, untreated or under-treated, costs

Back to School with the Esteem Hearing Implant

Posted by Envoy Medical Staff Member on August 17, 2018

Article written by an actual Esteem patient. He chooses to remain anonymous, but wanted people to understand how Esteem helped changed his life. (And with Esteem, no one needs to know you have it implanted.)

school work

School is not a fun place to be when you struggle with hearing loss. The worst is when a teacher calls on you, or someone is trying to ask you for a pencil, and they think you are ignoring them. It's also incredibly difficult to participate in a spelling bee when you can't hear the word you're supposed to be spelling. The truth is, I never wanted to wear hearing aids because I wanted to fit in and just be like everyone else. I didn't want to have to sit in the front of every class or be treated differently. The reality of the situation is that kids can be cruel and it's tough to grow in an environment where you are self-conscious about your hearing loss.  I was so self-conscious of wearing hearing aids that I let my education suffer as a result. I was constantly playing catch up and never felt like I was reaching my potential. I am convinced my head is full of grey hairs from being so stressed out all of the time in class because I never knew if someone was calling me or not. Quite frankly, I was embarrassed to admit that something was wrong with me. It got to the point where I was more focused on trying to hide my hearing loss than actually learning. Over time I learned to adapt and find ways to get through school, and learned what I needed to learn. Whether it was reading lips or being overly alert, I did what I had to do to get by.

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Topics: Esteem, hearing loss, recipients, testimonial, live well with hearing loss

Ten Summer Activities Made Easier with the Esteem

Posted by Envoy Medical Staff Member on June 1, 2018

Hearing aids can be a big-time pain in the summer and get in the way of enjoying your favorite summer activities. Moisture of any kind generally doesn’t do well with hearing aids, so humidity, sweat, summer rain showers, or having fun around water can spell trouble for your hearing aids. It usually means you either don’t participate, or participate but don’t hear. Below are ten summer activities made infinitely easier with the Esteem!

1. Biking. Comfortably wear a bike helmet and not worry about your hearing aid falling out on the road/trail or malfunctioning from perspiration.

2. Boating and swimming. You don’t have to worry about damaging your Esteem around water. Everything is internal, so nothing can get ruined from water. You can jump in and swim or waterski without even thinking about your Esteem. Or maybe you are watching kids or grandkids and need to be able to hear at all times and don’t want to worry about an external hearing aid falling out or being ruined from water exposure. It’s a delight not to have to worry about your hearing aids with the Esteem. sail boat

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Topics: Esteem, hearing loss, live well with hearing loss, hear everyday, all-day

Using your Esteem Near Water, While Swimming, and While Showering

Posted by Envoy Medical Staff Member on August 17, 2017

A conventional hearing aid can’t get wet. As models climb in price and add new features, a user still risks destroying a hearing aid when enjoying the lake or showering. If you enjoy swimming, you’re forced with the single option of leaving the hearing aid on your towel, giving up your aided-hearing while swimming, and sacrificing your situational awareness.

Envoy Medical knows how frustrating and nerve-racking this aspect of hearing loss treatment can be, and thanks to the Esteem, our users no longer need to give up hearing around water.

swimming in pool

For all Esteem users, the transition from dry to wet environments is seamless. This summer when you’re at the pool teaching your kids to swim, or enjoying a run through the sprinkler during a hot day, don’t worry about remembering to take your hearing aid out or, on the other hand, being able to hear when your hearing aid isn’t in your ear because you don’t want it to get wet.

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Topics: Esteem, live well with hearing loss, Safety, hear everyday, all-day

Hearing loss is a lifelong journey that can be an emotional roller-coaster. It can be daunting, frustrating, and isolating. It is important to know, however, that you are not alone. You are one of tens of millions of people live with some type and level of hearing loss. There is a broad community of people who understand what you are going through. 
 
That being said, your journey is unique, and how you approach your hearing loss is up to you. Hopefully, with the support and guidance of family, friends, and, of course, hearing healthcare professionals.  
 
The Sounding Board blog is designed to provide some insight on everything from general hearing loss topics to the specific experiences of individuals willing to share some stories from their personal journey.
 
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