Envoy Medical and the FDA Throw a Curve Ball

December 1, 2011

I had made an earlier trip to meet with Dr. Marzo at the Loyola University Center for Hearing in Oakbrook Terrace, IL in mid-October since I had planned to come up for the Northwestern Penn State game.  I am a huge Big Ten fan and had been adjunct faculty at Northwestern for 28 years (many of them 1-10 or 2-9 football years).

I grew up in Ohio as a Buckeye fan, have given lectures on the campuses of all of the original ten schools and paid tuition for a daughter at Illinois as well as attending every Big Ten basketball tournament game ever played. {Quiz—my wife and I both went to Ohio colleges where Woody Hayes was the coach and neither of us went to OSU].

I had studied the work of Dr. Shohet and Dr. Murray, the pioneers in Envoy Esteem, and felt comfortable going to either one.  Dr. Marzo started the Esteem implants after the March, 2010 FDA approval.  Envoy Medical representatives were complimentary, patients were finding success and his reputation and Loyola’s were good.  As in politics, character is important and the fact that he was an Evans Scholar (caddy scholarship program started by Chicago’s Chick Evans and a program well known to me) and the facility being in Chicagoland where I had a second home convinced me to meet with him. By that time, he had performed 30 implants and I was comfortable with this level of experience.

I met with Dr. Marzo on a crisp October morning and had my required CT scan in hand. He advised that I met the other criteria: 1) sensorineural loss, 2) healthy middle ear, 3) 40% plus speech discrimination, 4) hearing aid user more than 30 days--(10 plus years).  Dr. Marzo reviewed the CT scan and stated there was room in the mastoid to implant the device.  A new audiogram was prepared and appointments were made.

A battery replacement for the Envoy Esteem requires surgery with a local anesthetic and the cost is  $5000 to $7000.  The battery can last from 4.5 to 9 years based upon usage.  I had read the FDA finding and noted that a post-FDA study of 120 patients was required. I asked about this in the summer of 2010 and continued my inquiries.  Envoy Medical finally advised that a free battery replacement would be granted for participation.  It would require returns to the original surgery site about eight times over five years.  I was good with that and signed the papers.  Besides the freebie, I felt that the close monitoring would be beneficial to me and maximize my results as they would have a business interest in my success.

Pre-op baseline testing was required and three hours were set aside with Loyola’s audiology team on Thursday, December 1 for this purpose.

Lo and behold, the test had a curve ball--the hearing aids had to be programmed to specified criteria to the audiogram (I think that is what they said as I don't hear well, duh!).  This had never been stated in the literature or the FDA documents. I get hearing aid feedback due to the necessary gain required and we (my Florida audiologist and I) set the program a little below max.  I could easily have had the hearing aids programmed to the required criteria for 30 days prior to the pre-op.

I was dismissed from the post-FDA study and left the facility after only a 20 minute test somewhat down—not a good mood to be in for the 6:00 A.M. surgery appointment tomorrow..