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Comps > Middle Ear Implants > Flashcards

Middle Ear Implants Flashcards

1
Q

Describe normal middle ear anatomy and sound transmission.

A

In a normal ear, sound waves (acoustic energy) are picked up by the outer ear and converted to a mechanical sound by the tympanic membrane.

That mechanical energy travels through the ossicles and is converted to an electrical signal by the hair cells.

Nerve impulses are then sent to the brain by the auditory nerve.

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2
Q

Where in the auditory system is the damage with a SNHL and what is the result of this?

A

The hair cells are damaged resulting in poorer transmission of the signal to the brain.

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3
Q

What is the candidacy criteria for a MEI?

A

FDA–> Varies slightly across the different types of implants, but in general, indicated for a moderate to severe SNHL, people >18 years of age, normal middle ear, and trial with hearing aids.

Vibrant Soundbridge might be used for mixed and conductive but not indicated for this.

Carina also might be used for all types of hearing loss but it’s not FDA approved.

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4
Q

How does a middle ear implant work?

A

A middle ear implant works by converting mechanical vibrations in the middle ear to electrical signals.

The electrical signal is then transmitted to the processor of the implant where it is filtered and amplified before it is sent to the inner ear and then up to the auditory nerve and brain.

In other words, it is directly stimulating the cochlea by vibrating the ossicles.

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5
Q

What are the 2 kinds of MEI?

A

Fully implanted or partially implanted

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6
Q

What is a fully implanted MEI?

A

Implant with all components implanted

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7
Q

What is a partially-implanted MEI?

A

Requires use of an external sound processor

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8
Q

What are the 3 transducers used for MEI?

A

1) Piezoelectric
2) electromagnetic
3) electromechanical

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9
Q

What is a piezoelectric transducer?

A

Made of ceramic material that will change shape when a voltage is applied

Does not involve any magnets

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10
Q

What is an electromagnetic transducer?

A

Consists of a magnet and an energizing coil that combine to become a floating-mass transducer.

A magnetic field is generated when the coil is energized by a signal corresponding to an acoustic input.

The magnetic field causes the magnet to vibrate, in turn moving the ossicles and subsequently the fluid in the cochlea.

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11
Q

What is an electromechanical transducer?

A

Composed of the energizing coil and magnet housed in a single assembly.

The mechanical energy produced by the device is transmitted by a direct connection of the transducer to the ossicular chain.

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12
Q

What are the four middle ear implants available?

A

1) Esteem
2) Vibrant Soundbridge
3) Maxum
4) Carina ** Not FDA approved**

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13
Q

What is the Esteem MEI?

A

Fully implantable device designed with a sound processor and two piezoelectric transducers (a driver and a sensor)

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14
Q

Who created the Esteem?

A

Envoy Medical

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15
Q

What year was it FDA approved?

A

FDA–> 2010

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16
Q

How does the Esteem work?

A

Uses the natural acoustics of the ear canal

The sensor, which is implanted in the incus through the mastoid, picks up the sounds that travel to the middle ear and converts the vibrations of the ossicle to electrical signals.

The electrical signal is then sent to the sound processor where it is adjusted and amplified.

The driver then translates the modified electrical signals into intense vibrations of the stapes, which are transferred to the inner ear and then the brain.

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17
Q

What are the advantages of the Esteem?

A
  • Only fully implantable device
  • 24/7 hearing
  • No occlusion due to an open ear canal
  • No feedback
  • Device that is waterproof, windproof, and invisible
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18
Q

What are the disadvantages of the Esteem?

A
  • Cost (not covered by insurance)
  • Surgery under general anesthesia
  • surgery requires disarticulation of incudostapedial joint and mastoidectomy
  • Need for battery replacement under local anesthesia every 4.5-9 years
  • MRI limitations
  • Need adequate space in mastoid for device placement
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19
Q

What has research shown with the Esteem?

A

(Memari et al., 2011)

The average gain patients receive is 10-22 dB

High patient satisfaction with the device

20
Q

What are the complications with the Esteem?

A

(Memari et al., 2011)

  • Taste disturbance
  • Headaches
  • Facial nerve weakness
21
Q

True or false: A conductive hearing loss is created with the Esteem

A

True–> disarticulation of the ossicular chain creates a conductive hearing loss

22
Q

What is the Vibrant Soundbridge?

A

A partially implantable device with a battery similar to a hearing aid and an electromagnetic transducer.

23
Q

Who created the Vibrant Soundbridge?

A

Symphonix

24
Q

What year was the Vibrant Soundbridge FDA approved?

A

2000

25
Q

How does the Vibrant Soundbridge work?

A

The device consists of an external sound processor that is worn on the mastoid and held in place by a magnet, an internal implant below the skin, and a floating mass transducer (FMT) attached to the incus.

Acoustic sound enters the external sound processor where it is received and converted into an electrical signal.

This electrical signal is transmitted through the skin to the internal implant, which sends the signal along the conductor link to the FMT.

The FMT has a single point attachment with one ossicle and is responsible for converting the electrical signal to a mechanical signal.

This mechanical signal vibrates the ossicles, which in turn causes movement of the cochlear fluids and transmission of the signal to the auditory nerve and then to the brain.

About two months after surgery, an audiologist activates the device.

26
Q

What are the advantages of the Vibrant Soundbridge?

A
  • Only implant with a single-point attachment
  • The ability to upgrade the sound processor
  • An open ear canal
  • Insurance coverage
27
Q

What are the disadvantages of the Vibrant Soundbridge?

A
  • A surgery under general anesthesia
  • Use of an external device
  • MRI limitations
28
Q

Is the Soundbridge safe and effective?

A

(Frenzel et al., 2009)

Yes! In a small sample (n=7) of patients with unilateral hearing loss

29
Q

What did the third phase of a clinical trial with the Soundbridge show?

A

(Luetje et al., 2002)

  • 53 adults with moderate to severe SNHL
  • 5 months after surgery, residual thresholds were maintained (within 10 dB) for 51 patients
  • improvements in terms of functional gain, word recognition, and self-assessment compared to conventional hearing aids
30
Q

What is the Maxum middle ear implant?

A

Partially implanted device consisting of tin rare-earth magnet with an electromechanical transducer

31
Q

Who created the Maxum?

A

Ototronix

32
Q

When was the Maxum FDA approved?

A

2001 as the SOUNDTEC Direct Drive Hearing System (DDHS)
–Discontinued in 2004

2009 as the Maxum

33
Q

How does the Maxum work?

A

Attached to the incudostapedial joint through a transcanal approach

An integrated processor and coil (IPC) is placed in the ear canal and sends electrical signals across the tympanic membrane to the transceiver coil in the implant via electromagnetic energy.

The surgery is completed under local anesthesia and the device is activated about three weeks after surgery once the patient has healed.

34
Q

What are the advantages of a Maxum?

A
  • Cosmetics

- Minor surgery for placement of the device under local anesthesia

35
Q

What are the disadvantages of the Maxum?

A
  • Occluded ear canal

- MRI restrictions

36
Q

What has research shown about the Maxum?

A

Since it’s re-release in 2009, not many studies have been completed to assess outcomes with the Maxum.

However, small sample chart review of 6 ears in 4 patients showed a 25 dB improvement in functional gain over conventional hearing aids and 42% improvement in word recognition (Hunter et al., 2016)

37
Q

What are the surgical implications of the Maxum?

A

(Wade, 2002)

With the older SOUNDTEC:

  • inner ear trauma
  • Infection
  • TM perforation
  • Conductive hearing loss
38
Q

What is the Carina?

A

A battery operated, electromagnetic device that is fully implanted beneath the skin in the middle ear.

39
Q

Who created the Carina?

A

Otologics

40
Q

What year did the Carina receive FDA approval?

A

It’s not FDA approved

41
Q

How does the Carina work?

A

The implant consists of a microphone, a magnet, a battery, an electronic module, and an actuator.

The subdermal microphone picks up the acoustic signal and sends it to the implant where it is converted to an electrical signal and amplified.

The implant then sends the electrical signal to the actuator, which is placed on one of the ossicles, where it is converted to a mechanical signal that causes the ossicles to vibrate.

The sound transmission through the rest of the auditory system mimics that of a normal functioning system.

The Carina has a remote control that controls power, volume, and programs in the implant.

Additionally, the Carina has a battery that requires charging using an external device. The charger uses a coil with a magnet placed over the site of the internal implant on the head (like the coil/headpiece of a CI). The charger is left there for about an hour until the implant is fully charged.

42
Q

What are the advantages of the Carina?

A

Similar to the Esteem:

  • 24/7 hearing
  • No occlusion due to an open ear canal
  • No feedback
  • Waterproof, windproof, and invisible
43
Q

What are the disadvantages of the Carina?

A
  • Not FDA approved
  • MRI restrictions
  • requires surgery under general anesthesia
44
Q

What has research shown about the Carina?

A
  • Pilot study

(Lefebvre et al., 2009)

  • Showed no differences in pre- and post-op pure tone averages
  • Showed significant differences in functional gain and word recognition scores
  • No complications during surgery or 12 months following surgery
45
Q

What are the surgical implications of the Carina?

A

(Jenkins et al., 2007)

  • Conductive hearing loss
  • Device failure
  • Middle ear effusion
  • Headaches
  • Tinnitus
  • Aural fullness/pressure

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