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Can You Hear Me Now?An update on the latest technology and

solutions for hearing impairment

Linda S. MacConnell, PA-C

ENT Specialists of AZ

ASAPA Fall CME Conference

October 12, 2013

Learning Objectives

1. Differentiate various types and causes of hearing loss

2. Treatments for hearing loss

3. Explain how implantable devices could enhance their patient's lives

4. Determine in which patients implantable devices are appropriate

Hearing Impairment and Deafness in the USA

� ~28 million Americans with hearing loss

� ~700,000 have severe-profound hearing loss

� ~10% have received the benefit of a cochlear implant

� Hearing loss is the #1 birth defect in the US ~1-6 per 1000 babies are born with a significant hearing loss

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Audiometry

Decibels (dB) and %

• Strange scale; human ears are incredibly sensitive

• Range: Fingertip brushing skin to jet engines

• Smallest audible sound, almost total silence =0dB

• Jet engine is 1,000,000,000,000 (1 quadrillion) x more powerful than smallest audible sound

• Measures intensity of sound, exponentially

• 10 X more powerful is 10dB, 20 dB =100 x more powerful, 1000 X more powerful = 30dB

Comparison of Sounds and Decibels

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How Hearing Works: Natural Hearing

How Hearing Works: Hearing Aid

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“Typical Hearing Aids”

• Acoustically amplify

sound

• Require functional

hair cells

• Programmable

amplifiers

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Optimum Hearing is Bilateral

>

• Direction of sound

• Differentiation of sound

• Quality of sound

Input from both ears means potentially enhanced:

Hearing Aids vs Cochlear Implants

� Hearing aids amplify sounds

� Programmable

� Rely on surviving hair cells responding

� Bypass hair cells directly stimulating the nerve of hearing

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Bilateral = input to 2 ears

Bimodal = a different mode in each ear, CI+HA

Bilateral and Bimodal Hearing

Ability to receive input from both ears:

How Hearing Works: Cochlear Implant

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Cochlear Implant

� Children 2-17: severe-to-profound SNHL

� Children 1-2 years: profound SNHL

� Adults: moderate-to-profound SNHL

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• Internal implant placed just under the skin, behind ear

• External sound processor sits behind ear

•Sound Processor Headpiece, Transmitter Antenna and Cable

•Internal Cochlear Stimulator with Receiver Antennaand Electrode Array

•Sensory receptors, (hair cells) are damaged

•Some auditory nerves survive

•Damaged hair cells unable to transmit electrical impulses to surviving nerves

•Auditory signals not sent

Cochlear Hearing Loss

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Cochlear Implants

Bypass damaged hair cells

to stimulate the nerve directly

How a CI Works

A sound processor (1) captures sound with a microphone and converts it into detailed digital information.

Digital signals are sent from the headpiece (2) to the implant, where they are converted into electrical signals.

Signals travel to a tiny electrode array(3) placed inside the cochlea.

Electrode array sends electrical signals directly to the hearing nerve (4), bypassing damaged cells. These signals are then sent to the brain, where they are interpreted as sound.

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Anna MacConnell CI Photos

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Who is an adult CI candidate?

Limited benefit from HA

• Difficulty communicating 1:1, even in quiet room

• Need captions for TV

• Avoid social activities

• Depend on lip-reading to understand conversation

• Trouble hearing on phone

• No longer enjoy music

Pre-implant: CI Candidate

Anthem/Wellpoint Criteria (Surg.00014)

Unilateral or bilateral implantation of a U.S. Food and Drug Administration (FDA) approved single or multi-channel cochlear implant is considered medically necessaryin an individual with bilateral severe-to-profound pre or postlingual hearing loss (sensorineural deafness), defined as speech reception of 70 (dB) or greater, when all of the following criteria are met:

1. The individual, including those with hearing loss due to meningitis, cannot benefit from conventional hearing devices; and

2. The individual is free from lesions in the auditory nerve and acoustic areas of the central auditory pathway (nervous system); and

3. The individual is free from otitis media or other active ear infections; and

4. The individual is able to participate in a post-cochlear rehab program in order to achieve benefit from the cochlear implant

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Pediatric Candidacy CriteriaAudiometric candidacy ranges: 2-17 y.o. – severe-to-profound

SNHL in both ears; 12-24 mos. – profound SNHL in both ears

* Test material typically presented @ 60 dB SPL

Speech recognition criteria*

2-17 yrs:Limited benefit from binaural amplification trial

12-24 mos:Limited benefit from binaural amplification trial

Who is a pediatric CI candidate?

1. Little or no benefit from appropriately fitted hearing aids

2. Parent or teacher reports:

3. Lack of speech and language progress

4. Rarely responds to name

5. Lack of social interaction with children or adults

6. Able to participate in post-implant rehab to achieve benefit from CI

Pre-implant: CI Candidate

Contraindications*• Deafness due to lesions of the acoustic nerve or central

auditory pathway

• Active middle ear infection: Tympanic membrane perforations in the presence of active middle ear disease

• Absence of cochlear development (congenital)

• Psychological contraindications

• Medical contraindications to surgery

• Unrealistic expectations

• Disabilities that may limit participation in rehabilitation (differs depending on situation)

* Cochlear Nucleus Cochlear Implant System Physician’s Package Insert

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Predicting Success

• Duration of deafness

• Mode of communication

• Commitment / motivation to get a CI

• Determine candidacy based on word recognition in addition to hearing thresholds

• Earlier is better…but, it’s never too late to become an implant recipient

How Hearing Works: BAHA System

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Cochlear Bone Anchored Hearing Aid (BAHA)

Osseointegrated auditory implant system for individuals* with unilateral profound hearing loss (single-sided deafness), mixed or conductive hearing loss

*Implant appropriate for aged >5 years old. Younger children may use the BahaSoftband system

Cochlear BahaSystem

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- Conductive hearing loss- Mixed hearing loss- Single-sided deafness

BAHA Indications

Cochlear Baha System

• Direct bone conduction system

• Adults & pediatrics aged 5 and older

• Younger children may use the Baha Softbandsystem

• Osseointegration (fusion of implant and bone) = 3 mos. for adults, typically 6 mos. for children

• Fully functional demos can be used in the office

Cochlear Baha SystemProven performance28

• As the air/bone gap increases, hearing aid performance decreases

• Baha System performance is not affected

28 Snik AF et al. (2005) Consensus Statements on the BAHA System: Where Do We Stand at Present? Annals of

ORL 114(12S). 195:1-12.

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Cochlear Baha System

Titanium implant placed in the bone behind the ear

An external sound processor which connects to the implant via an abutment

Cochlear Baha System

System Components

Baha 3 Sound Processor

Picks up sound and converts to vibration

Transfers vibrations from sound processor to implant

AbutmentImplant

Titanium - placed in bone behind ear where it osseointegrates and transfers vibrations directly to cochlea via bone conduction

Indications for treating hearing loss with the BahaSystem:

• Conductive hearing loss• Mixed hearing loss• Single-sided deafness

BAHA System Candidacy Criteria

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Cochlear Baha System: Indications

> < 5 years of age: Softband only

> ≥ 5 years of age: Implantation

> ≤ 65 dB HL BC PTA

> Mixed/conductive hearing loss, single-sided deafness

CholesteatomaChronic otitis media Congenital atresia

Conductive Hearing Loss

Candidacy criteria

O OO O OO

< < << <

Conductive Loss

Mixed Loss

Single Sided Deafness (SSD)3

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1

An implantable bone-anchored hearing aid is considered medically necessary for individuals who meet the criteria specified in either (A) or (B), below.A. An implantable bone-anchored hearing aid is considered medically necessary as an alternative to an air conduction hearing aid for individuals five years of age and older who meet both audiologic and medical condition criteria as follows:

1. Audiologic criteria (must meet one):Bilateral implant: Moderate to severe bilateral symmetric bone conductive or mixed (conductive

and sensorineural) hearing loss. Symmetric bone conduction threshold is defined as less than:b. 10 decibels (dB) average difference between ears (measured at 0.5, 1, 2, and 4 kilohertz

[kHz]), or less than a 15 dB difference at individual frequencies (BAHA Divino™); ora. 10 dB average difference between ears (measured at 0.5, 1, 2, and 3 kHz), or less than a

15 dB difference at individual frequencies (BAHA Cordelle II; BAHA BP100; BAHA Intenso™); ORUnilateral implant: Conductive or mixed (conductive and sensorineural) hearing loss with pure

tone average (PTA) bone conduction hearing threshold better than or equal to 45 dB hearing loss (HL) (BAHA Divino, BAHA BP100), 55 dB HL (BAHA Intenso), or 65 dB HL (BAHA Cordelle II).

2. Medical condition criteria (must meet at least one):Congenital or surgically induced ear malformations of the external or middle ear canal

(e.g., atresia); orSevere chronic external otitis or otitis media; orTumors of the external ear canal or tympanic cavity; orDermatitis of the external ear canal, including reactions from ear molds used in air

conduction hearing aids; orOther anatomic or medical conditions that contraindicate the use of an air conduction

hearing aid.B. An implantable bone-anchored hearing aid is considered medically necessary to improve speech recognition in individuals five years of age and older with unilateral sensorineural hearing loss (i.e. single sided deafness) while the other ear has normal hearing. Normal hearing is defined as PTA air conduction (AC) threshold equal to or better than 20 dB HL at 0.5, 1, 2, and 3 kHz.C. A transcutaneously worn BAHA (bone conduction-type hearing aid) utilizing a Headband or Softbandis considered medically necessary as an alternative to an implantable bone anchored hearing aid or air conduction hearing aid in individuals who meet the criteria specified in either (A) or (B), above, except for the age limitation of 5 years of age and older which does not apply for a transcutaneously worn BAHA.

Anthem/Wellpoint Criteria for BAHA

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Conductive Hearing Loss

Candidacy criteria

O OO O OO

< < << <

Conductive Loss

Mixed Loss

Single Sided Deafness (SSD)3

2

1

Conductive Hearing Loss

Aided outcome

Unaided audiogram Aided audiogram

OO O

O O O

< < << <

BB B

B B

Mixed Hearing Loss

Candidacy criteria

<

<< <

<

O O OO O O

Conductive Loss

Mixed Loss

Single Sided Deafness (SSD)

1

2

3

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Mixed Hearing Loss

Aided outcome

<<

< < <

OO

O O O

Unaided audiogram Aided audiogram

B B B BB

Single Sided Deafness (SSD)

Candidacy criteria

Unaided audiogram

x x x xx

Conductive Loss

Mixed Loss

Single Sided Deafness (SSD)

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2

3

Single-Sided Deafness

Key indications

• One ear = sensorineuraldeafness

• Other ear = normal

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Single-Sided Deafness

The purpose of the BahaSystem for SSD is to provide sufficient amplification force to overcome the head transfer function.

Eg: Acoustic neuroma

Impact of SSD

• Difficulties adults experience:

� Hearing in background noise

� Localization

� Understanding a person situated on the deaf side

• Difficulties of children with unilateral hearing loss:

� Speech and language delay

� Difficulty paying attention in school

� Difficulty hearing in noisy environments

� Difficulty localizing sounds

Single-Sided Deafness (SSD)

Aided & unaided outcomes

Unaided audiogram Aided audiogram

BB B

BBx x x x

x

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Questions???