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ABOUT THE SOPHONO
This is a relatively new device introduced into the UK in November 2011. It was developed in Germany then bought by an American company.
Its great advantage over previous devices is that there is nothing sticking through the skin. So no long term looking after the implant site and no risk of infections around a protruding abutment.
There are two parts:
An INTERNAL part – which goes underneath the skin and contains two magnets.
An EXTERNAL part – which is on the outside of the skin and is held in place by a magnet over the internal part.
Who Might Benefit From A SOPHONO?
Three groups of people may benefit from a Sophono:
1. Patients with a CONDUCTIVE hearing loss
2. Patients with a MIXED loss.
3. Patients with a ONE SIDED severe to profound nerve hearing loss (= a sensori-neural hearing loss)
This is where sound can not get through to the inner ear. Possible causes are listed below. Often this sort of hearing loss can be treated with a normal hearing aid but some people can not use a normal hearing aid either because it causes ear infections or because the patient may not have an ear or ear canal.
For people with a conductive hearing loss and repeated infections whenever they use a normal hearing aid, the Sophono can be effective at not only helping the hearing but also allowing the ear to dry up and avoid infections because the ear canal is no longer blocked.
Causes of a conductive hearing loss where the Bonebridge may help:
- abnormal or absent pinna
- blocked or absent ear canal
- recurring ear canal infections
- chronically infected hole in the ear drum
- any cause of a conductive hearing loss where a normal hearing aid causes problems.
The Sophono allows the sound vibrations to bypass any problems in the ear canal or middle ear and to go straight to the healthy cochlea.
In some people with a conductive hearing loss the inner ear is also not working very well. For these people a certain degree of amplification is needed.
The SOPHONO claims to provide enough amplification as long as the nerve hearing loss is not greater than 40dB.
For the time being I am only implanting people with a pure conductive hearing loss – in other words people who have a conductive problem but with a normal nerve hearing. I want to wait and see some more long term results for patients with an added nerve hearing loss.
People who have only one hearing ear often have a lot of problems:
- hearing people on their deaf side
- hearing in background noise
- localising where sounds come from
A normal hearing aid doesn’t work because the inner ear on that side is not working. However if the other ear has normal nerve hearing then the output from a bone conduction device will reach that normal nerve allowing the patient to hear.
Causes of a single sided deafness:
- Trauma
- Viral infection
- Labyrinthitis
- Severe Menieres disease
- Sudden sensori-neural hearing loss
- Acoustic neuroma removal
- Congenital (i.e. born with only one hearing ear)
The Sophono is attached to the deaf side. When someone speaks on the patients deaf side the sound is picked up by the Sophono microphone. The Sophono device vibrates the skull sending sound to both cochleas (inner ears). The good cochlear on the other side will detect the sound and convert it to nerve impulses and send it up to the brain so the patient can hear that person speaking.
The Operation
A U shaped skin incision is performed just slightly above and behind the ear. No hair is shaved off.
The skin flap is lifted up and the underlying bone is exposed. Two shallow wells are drilled into the bone.
The two magnets of the internal device fit into the two wells. The device is then anchored to the skull with tiny screws.
If the skin flap is very thick then it is thinned down otherwise the magnets may not be strong enough to hold the outside part is place.
The skin flap is replaced and stitched closed with dissolvable stitches. A pressure bandage is put around the head for a few hours. The bandage is then removed and you can go home.
The operation can be performed under a local anaesthetic or a general anaesthetic.
It takes about 45-60 minutes to perform.
You should not wash your hair for 10 days.
The operation can be performed on the NHS in some parts of the country.
Nothing sticks through the skin.
The new Alpha 2 hearing aid part held in place by magnets.
The Risks of the Operation
There are very few risks.
Infection and bleeding
are risks of any operation. Infection is unusual in the scalp because of the very good blood supply. If infection does occur and spreads to involve the internal device it may need to be removed. This is extremely rare. Bleeding risk is minimised by careful surgical technique and a pressure dressing which is applied at the end of the operation and left on for at least 3 hours.
Damage to the dura.
The dura is the thick lining that covers the inner surface of the skull. The recesses drilled in the skull to hold the magnets are shallow so it is very unusual for the dura to be exposed. Even if it is exposed this is not a problem and is quite a common occurrence in other types of implant operation. Damage to the dura could possibly lead to bleeding inside the skull. This is extremely rare and is also a risk of the other type of bone anchored hearing aid known as a BAHA.
Skin problems:
Irritation of the skin from pressure of the magnets. This is unusual but if it happens then a weaker magnet can be used.
Ulceration of the skin. If this occurs you will not be able to use the external device until the skin heals. If it happens despite using the weakest magnet then the device will need to be removed.
Previous experience has suggested a 4-8% risk of skin problems most being simple reversible reddening of the skin.
External device keeps falling off. This my happen if the magnets are not strong enough. Stronger magnets can be used but if this does not work the skin flap may need to be thinned. A very thick skin flap will be thinned at the time of the original surgery.
MRI scan:
At the present time you will NOT be able to have an MRI scan with this device in place. The MRI scanner may demagnetize the magnets. If an MRI scan is required the device will need to be removed and replaced at a later date. Work is going on to see if it is possible to have an MRI scan without affecting the magnets and so it may be that this restriction will be lifted in the future. At the present time if an MRI scan is needed the internal part would need to be removed and replaced later.
AFTER THE OPERATION
The skin incision needs to be kept dry for about 10 days. After this you can get the area wet and there are no restrictions on any activities.
The external device will be given to you about 4 weeks after the operation and tuned in by the Audiologists.
Manufacturers
The Sophono is made by Sophono Inc and their website can be found at: