Interview with Stephen Harner MD, Mayo Clinic, Rochester, Minnesota
AO/Beck: Hi Dr. Harner. Thank you very much for sharing your time with me today.
Harner: Hi Dr. Beck, thanks for inviting me.
AO/Beck: Dr. Harner, before we get into the discussion about middle ear implants, I'd like to obtain a little of your professional history, if you don't mind?
Harner: Sure. I went to medical school at the University of Missouri graduating in 1965. My internship was at Brook Army Medical Center and my residency in otolaryngology at Fitzsimmons Army Hospital in Denver. My specialty is otology/neurotology. I started at the Mayo Clinic, Rochester, MN in 1973, and I've been here ever since!
AO/Beck: Very good. Let's start with your experience with middle ear implants. I know it's a little bold of me to ask, but if I may, how many have you implanted?
Harner: As of this moment, I have implanted four units, I have two scheduled for later this month, and another one scheduled in September. I first became interested in middle ear implants many years ago, but my enthusiasm and interest really deepened when the FDA first approved them, in August 2000.
AO/Beck: While reflecting on the 4 units you've implanted, are there any general observations you can make?
Harner: Yes. My experience, and more importantly the patient's experience, has been very positive and I have enjoyed working with the device.
AO/Beck: Who can be considered a candidate for middle ear implant surgery?
Harner: The selection of the patients from a medical point of view has been fairly straightforward. The patient needs to have a sensorineural hearing loss, also called a sensory loss, a nerve loss, or a cochlear loss. They also need to have tried traditional hearing aids before they can be considered a candidate for a middle ear implant.
After using traditional hearing aids, and if they are frustrated by feedback, having their ear occluded, or inadequate sound quality, they are potential candidates for a middle ear implant. As the patient is being medically evaluated for a middle ear implant, the audiologist works with them to make sure the patient understands what the unit is, what it looks like, how it works, and for audiometric testing.
If the audiologist and I agree that the patient is a good candidate, has the appropriate type and degree of hearing loss, has had appropriate counseling, and adequate amplification experience, then we offer the middle ear implant as an alternative.
AO/Beck: Can you please describe the surgical procedure for me?
Harner: Yes. From the surgeon's perspective, the procedure is straightforward, and involves anatomy we work with every day. The procedure is done on an outpatient basis. The surgery takes about two hours, with the patient under general anesthesia. Basically, we perform a mastoidectomy, open up the area between the mastoid and the middle ear to insert the transducer and then the remainder of the device is inserted beneath the skin behind the ear. The patients come back to the office the day following surgery, and returns again about 6 weeks later.
AO/Beck: And if everything has healed OK, and is doing well, do they go on to get tuned-up during that office visit?
Harner: Yes. After I check the surgical site and make sure everything is fine, they see the audiologist. The audiologist adjusts the external processor for the appropriate listening levels, and that's about it.
AO/Beck: Dr. Harner, what are the contra-indications for a middle ear implant? In other words, what situations might disqualify a patient from receiving an implant?
Harner: If the patient has had previous surgery in the middle ear or mastoid, he would not be a candidate. For example, if they've previously had a cholesteatoma or a chronic draining ear, they are not going to be a middle ear implant candidate. Additionally, if the hearing fluctuates, as in Meniere's syndrome, the patient is not going to be very good candidate. I wouldn't recommend an implant for a patient who has autoimmune inner ear disease. Another concern is the word recognition score - that is, how clearly the patient understands words. If the patient understands, and just need sound to be louder, great, he is probably a middle ear implant candidate. If his word recognition scores are low, the implant won't be of much assistance.
AO/Beck: Have your patients received unilateral (one ear) implants?
Harner: Yes, all of my patients are unilaterally implanted. Nonetheless, I can certainly see that some patients will benefit from bilateral implants.
AO/Beck: Can you give me any information about insurance and third party payment for the middle ear implant?
Harner: At the present time coverage is case by case. Although the FDA approved the implant, Medicare coverage varies. Other insurers are covering at least the surgery and some are covering the surgery and the implant. The best approach for the patient to take is to let the physician's or the audiologist's office contact the insurance company to verify coverage. When the office personnel contact the insurance company with the necessary data, the experienced insurance personnel are more receptive than if the patient contacts them directly. The patient can always get involved if there is an appeal. Most new procedures require time before coverage becomes widespread. Reimbursement will get better.
AO/Beck: What can you tell me about the observations and the subjective comments your patients report back to you?
Harner: My patients are all very pleased. They report an improved sound quality over their hearing aids. They report no feedback, and they like having their ear canals open.
AO/Beck: Any predictions for the next 3 to 5 years? If you look into your crystal ball, where do you see middle ear implants in the next few years?
Harner: I think the next major step will be a totally implantable device. The Vibrant Soundbridge is very good, and the patients do very well. Nonetheless, if it was totally implantable, with no external components that would be perceived by the patients as even better and I think that's where we're headed.
At the same time having an internal and an external device has some advantages. As technology changes and improves you never need to have additional surgery - all you do is swap out the external processor for the better, more sophisticated unit.
AO/Beck: Dr. Harner, I know your time is very valuable and I thank you for sharing your insight on this topic with us today. Perhaps we can get together again in the fall for a follow-up discussion?
Harner: That would be great. I'll look forward to speaking with you then.
AO/Beck: Thank you very much.
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