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New BAHA Unit for Mild to Moderate Hearing Losses – Intenso
By J.P. Miller, M.S. CCC-A

The Cochlear Corporation recently introduced the newest member of its Bone anchored hearing aid (BAHA) lineup, the Intenso.  This small, digital, head-worn device has been developed for persons with a mild to moderate hearing loss.

To date the number of options for power users had been limited to the Cordelle, a body worn unit.  But now users in the 45 to 55dB HTL hearing loss category can enjoy the power of the Intenso unit.  The digital unit has two programs controlled by a switch on the side of the case.  The second program is designed for noisy environments.  The Intenso also has a built in active feedback mechanism which controls feedback by the cancellation method.

Who can benefit from the Intenso?

Patients with conductive hearing losses.  Sometimes chronic ear infections can prevent a person from putting a conventional hearing aid/and or earmold in their ear.  They might also have problems in the outer ear canal such as chronic drainage.  Then there are some patients born with congenital hearing problems like Atresia.  The outer portion of the ear may not be totally formed at birth and there also may be malformations in the middle ear.  

The Baha system utilizes direct bone conduction, which allows the bone to transfer sound to a functioning cochlea – thereby bypassing the middle ear.  This unique hearing treatment is the only system of its kind cleared by the Food and Drug Administration (FDA) to treat hearing loss.

One reason the Baha system works so well is due to its simple design. The Baha system combines a sound processor with an abutment and a small titanium implant. The implant is placed behind the non-functioning ear. Surgery is minor, and Baha recipients report a wide range of advantages over other hearing devices.   

Patients with mixed hearing loss.  Mixed hearing loss combines elements of conductive hearing loss along with hearing loss in the inner ear.  Now the Intenso unit allows patients to be fitted with a more powerful head-worn device. Previously the only other digital unit available was the Devino which reportedly could be used for mild to moderate hearing losses.  But often times users with a moderate hearing loss desired more gain than the Divino could deliver.

Single Sides Deafness (SSD).  Patients who have totally lost the hearing in one ear but have normal hearing in the other ear can be helped by the Intenso device.   The processor can pick up the sounds on the dead ear side and then send them to the good ear through direct bone conduction.   

The BAHA system is the only implanted treatment for hearing loss that works through direct bone conduction.  It was first utilized in Europe in 1977 and   first cleared for use in the United States by the FDA in 1996.  Three years later, the BAHA was given clearance for use in children age five years and older.  Then in 2002, the BAHA was recognized for treatment of single Sided Deafness, affecting more than 60,000 Americans a year.

Last year the Cochlear Corporation, makers of the Freedom cochlear implant devices, acquired the BAHA system from Entific Medical, based in Goteborg, Sweden.  They plan to continue to promote the BAHA system and develop new products for the hearing impaired population.

 

 

Bone Anchored Hearing Aid

BAHA(R) (Bone Anchored Hearing Aid) is a hearing aid system manufactured by Cochlear Corporation. The BAHA is primarily designed for people who have conductive hearing losses. The BAHA is also suitable for someone with mixed hearing losses who cannot otherwise wear 'In the ear' or 'behind the ear' hearing aids. Entific, a Swedish company, was recently bought out by the Australian company Cochlear.

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The BAHA works by direct conduction via a small titanium abutment which is screwed into a titanium fixture which is implanted in the skull. The titanium fixture bonds with the surrounding tissue over three to six months after surgery in a process called osseointegration. The BAHA hearing aid device can be used once osseointegration is complete, usually three to six months after implantation.

The BAHA hearing aid device itself has a patented snap-lock coupling which allows it to clip into the abutment. The BAHA is then treated as a regular hearing aid, running on small circular batteries which last approx 6-14 days. The snaplock coupling is designed to detatch upon impact as a safety feature to prevent damage to the implant or surrounding tisses.

Who is a suitable candidate for a BAHA

The usual candidates for a BAHA system are those people who for a variety of reasons cannot wear standard 'in the ear' air conduction hearing aids or who would benefit most from amplification by bone conduction.

  • Some people have allergies to earmoulds or cannot have moulds in their ears due to irritation or infection which can become chronic.
  • People who have malformed or absent outer ear and ear canals as is common in medical conditions such as Treacher Collins syndrome or Microtia
  • People who have single sided deafness due to surgery, head trauma or disease. For example people who have meniere's disease.
  • In Canada, stage one surgery for BAHA has been implanted into children as young as 13 months at the Hospital for Sick Children in Toronto. Stage two surgery has been done as early as 22 months.
  • For infants, an interim measure young infants can be provided with a BAHA softband allowing them to use a BAHA. This is a tight headband which the infant wears to hold a BAHA against the skull.

Audiological Criteria for BAHA System

The FDA lists the following criteria for BAHA use in Mixed and conductive losses.

Greater than or equal to 5 years of age

Less than or equal to 45dB HL bone conduction pure tone average (frequencies 0.5, 1, 2, 3kHz) and greater than or equal to 60% speech discrimination scores

For bilateral fittings – Symmetric bone conduction thresholds are defined as less than 10dB difference on average (0.5, 1, 2, 3kHz) or less than 15dB at individual frequencies.

The FDA lists the following criteria for BAHA use in Single Sided Deafness.

Greater than or equal to 5 years of age

Normal hearing in contralateral ear.  Normal hearing is defined as a pure tone average for air conduction thresholds equal to or better than 20dB HTL at .5, 1, 2, 3kHz.

Functions by transcranial routing of signal

 

BAHA devices available

There are currently four types of BAHA available. The Cordelle, Classic, Compact and Divino.

  • BAHA Cordelle II A bodyworn BAHA for people with a severe hearing loss who need more amplification than the other BAHAs available. The Cordelle II comprises of a transducer which snaps onto the abutment and a bodyworn unit. This is the only BAHA to have an induction telecoil receiver built in.
  • BAHA Classic 300 This is the older BAHA device which has been mostly superseded by the Compact and Divino but is still worn by those with more severe and mixed hearing losses. This will be discontinued in Feb 2007, with repairs ceasing to out of scheme models after that.
  • BAHA Compact Rated as identical to the Classic but found to be slightly less powerful by a few users. The Compact is 33% smaller than the Classic and has added AGCo and improved shielding from mobile telephone signals. Until Jul 2005 the compact was the latest model.
  • BAHA Divino Newly released in July 2005 this is the long awaited digital BAHA which has a built in directional microphone. While some people are disappointed that the digital options were not very flexible, new users are said to be very happy with it.

BAHA Surgical Procedure

In recent years improvements to the surgical procedures have resulted in most patients being able to have a single stage procedure carried out under local, or a short general anaesthetic. Most patients are able to leave hospital within a few hours, or the day after their procedure with many not even requiring analgesia in the following days.

Osseointegration is the process of the titanium fixture bonding to the bone. There is a high success rate for osseointegration above 95% according the latest studies in medical journals. Occasionally infection and other problems will prevent osseointegration from being successful. In these cases the patient will be given time to heal and further more cautious attempts at the surgical procedure can be made.

Procedure for Very Young Children - Two Stage Operation A double stage procedure is sometimes carried out for small children / babies or other medical reasons. The first stage involves peeling back a small 1cmx1cm section of skin behind the ear, then drilling one or more holes for the fixture. (Some surgeons will place a "sleeper" receptor.) The skin is then grafted back and the child waits for the skull to continue to thicken and for osseointegration to occur properly. After osseointergration (can be 6-8 months) the second stage os performed. The second stage is another surgery in which the "post" is attached, and the skin is grafted around the "post" This will require healing for several weeks, at which point the Baha would be fitted.

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