The CI for children issue (My POV)

[jillio]

My daughter's surgeon is extremely conservative. He does not implant befor 12 months, but he implanted Miss Kat even though she did not meet the FDA guidelines. He did not petition at all. Where are you getting the information that they must petition? I have never heard of such a thing.

Directly from the FDA. How do you know he didn't petition? You didn't even know it was required. Plus, there would have been no need for him to petition. Miss Kat was well over the age requirement.

 

[faire_jour]

An ABR is a screener. They are not for diagnostic levels, nor can one test for discrimination abilities or get an accurrate dB level. Input from the child is required for definitive diagnosis.

A sedated ABR can go frequency by frequency. It is considered diagnostic.

• Diagnostic ABR assessment:
o Obtain a threshold search to a click ABR in 10 or 20 dB steps (this varies by clinic however 10 dB steps
are recommended, particularly when approaching threshold)
o Tone bursts at 500 Hz or 1000 Hz and at a high frequency (3000 Hz or 4000 Hz)
o Responses should be assessed at 90-95 dB nHL if no responses are observed at softer levels.
o If an absent ABR response is noted, it is recommended that a study be performed comparing a high
intensity (90dB nHL) rarefaction click stimulus to a high intensity condensation click stimulus to
determine if cochlear microphonic reversal occurs when the polarity of the click stimulus is reversed. If
there is cochlear microphonic reversal combined with an absent Wave V response, auditory dyssynchrony
should be suspected. Correlation with OAE should be made.
o Bone conduction click ABR if air conduction click ABR threshold is elevated or abnormal
o Click ABR at a high intensity to assess the latency and morphology of I, III, V, I-III, III-V
and I-V for the purpose of retro-cochlear evaluation (optional)

 

[faire_jour]

Directly from the FDA. How do you know he didn't petition? You didn't even know it was required. Plus, there would have been no need for him to petition. Miss Kat was well over the age requirement.

But she was audiologically outside the guidelines.

 

[shel90]

But she was audiologically outside the guidelines.

:scratch: Can you explain what you mean pls?

 

[faire_jour]

:scratch: Can you explain what you mean pls?

For children over 2, you need a severe to profound loss.

Miss Kat's loss was moderately severe-profound. She was not within the guidelines.

 

[jillio]

A sedated ABR can go frequency by frequency. It is considered diagnostic.

• Diagnostic ABR assessment:
o Obtain a threshold search to a click ABR in 10 or 20 dB steps (this varies by clinic however 10 dB steps
are recommended, particularly when approaching threshold)
o Tone bursts at 500 Hz or 1000 Hz and at a high frequency (3000 Hz or 4000 Hz)
o Responses should be assessed at 90-95 dB nHL if no responses are observed at softer levels.
o If an absent ABR response is noted, it is recommended that a study be performed comparing a high
intensity (90dB nHL) rarefaction click stimulus to a high intensity condensation click stimulus to
determine if cochlear microphonic reversal occurs when the polarity of the click stimulus is reversed. If
there is cochlear microphonic reversal combined with an absent Wave V response, auditory dyssynchrony
should be suspected. Correlation with OAE should be made.
o Bone conduction click ABR if air conduction click ABR threshold is elevated or abnormal
o Click ABR at a high intensity to assess the latency and morphology of I, III, V, I-III, III-V
and I-V for the purpose of retro-cochlear evaluation (optional)

Once again, sedated allows for no input. Talk to your audi and your surgeon. They will tell you that you cannot get diagnostic functionality readings without input from the subject. Too many variables involved to determine such from frequency and dB rates alone.

 

[jillio]

But she was audiologically outside the guidelines.

We are discussing age requirements. Surgeons are allowed some discretionary leeway when it comes to audiograms. Why. For the very reason I cited above. Testing does not demonstrate functionality unless it is moderated in interpretation by patient input.

 

[faire_jour]

Once again, sedated allows for no input. Talk to your audi and your surgeon. They will tell you that you cannot get diagnostic functionality readings without input from the subject. Too many variables involved to determine such from frequency and dB rates alone.

I know for a fact that audiologists consider an ABR diagnostic. That is why they use it. They later use booth tests to fine tune, when the child is able to give input, but there are thosands of kids who are getting hearing aids based an ABRs.

 

[faire_jour]

We are discussing age requirements. Surgeons are allowed some discretionary leeway when it comes to audiograms. Why. For the very reason I cited above. Testing does not demonstrate functionality unless it is moderated in interpretation by patient input.

Then why not age? I have talked to several surgeons and NONE of them have ever said that they need permission. That is why it is called a guideline.

 

[faire_jour]

We are discussing age requirements. Surgeons are allowed some discretionary leeway when it comes to audiograms. Why. For the very reason I cited above. Testing does not demonstrate functionality unless it is moderated in interpretation by patient input.

Young children can not give feedback. At 6, 8 or 10 months they can not do dicrimination tests. How do you explain that they are getting implants?

 

[jillio]

I know for a fact that audiologists consider an ABR diagnostic. That is why they use it. They later use booth tests to fine tune, when the child is able to give input, but there are thosands of kids who are getting hearing aids based an ABRs.

Do you know the difference between a diagnostic screener, and a diagnostic assessment? You do not get a definitive diagnosis from a screener.

 

[faire_jour]

Do you know the difference between a diagnostic screener, and a diagnostic assessment?

The newborn hearing screen and a diagnostic ABR are different.

 

[jillio]

Then why not age? I have talked to several surgeons and NONE of them have ever said that they need permission. That is why it is called a guideline.

Because age is not subjective, it is not subject to moderation from extraneous variables, and it does not change based on environmental concerns.:roll: Just because someone never told you it had to be done does not mean it doesn't. Age is not a guideline, it is as criterion.

 

[jillio]

The newborn hearing screen and a diagnostic ABR are different.

Then why are you arguing with me? We are talking about newborn screening.

 

[faire_jour]

Because age is not subjective, it is not subject to moderation from extraneous variables, and it does not change based on environmental concerns.:roll: Just because someone never told you it had to be done does not mean it doesn't. Age is not a guideline, it is as criterion.

And just because you say it is true, doesn't make it so. Offer up some proof. All I have is your say so.

 

[faire_jour]

Then why are you arguing with me? We are talking about newborn screening.

I'm not. I'm talking about the follow up diagnostic ABR. It is without input from the patient and it is diagnostic. It can happen as soon as the child fails the screen. They are then ID'ed and diagnosed with a specific hearing loss and fitted with amplification. It is not true that you need their input for diagnosis, or that you can not diagnose a newborn.

 

[jillio]

I'm not. I'm talking about the follow up diagnostic ABR. It is without input from the patient and it is diagnostic. It can happen as soon as the child fails the screen. They are then ID'ed and diagnosed with a specific hearing loss and fitted with amplification. It is not true that you need their input for diagnosis, or that you can not diagnose a newborn.

This all started with you attempting to correct me regarding something I said regarding newborn screenings, implantation at birth and implantation at 6 months. That was all in the context of discussing linguistic delays that occur from the moment of birth with another poster. If you are changing the context of an ongoing conversation, it is not necessary to quote me. That implies that you are referring to the context that was being discussed.

 

[jillio]

And just because you say it is true, doesn't make it so. Offer up some proof. All I have is your say so.

You can easily check for yourself. Doesn't require any special skills.

 

[faire_jour]

This all started with you attempting to correct me regarding something I said regarding newborn screenings, implantation at birth and implantation at 6 months. That was all in the context of discussing linguistic delays that occur from the moment of birth with another poster. If you are changing the context of an ongoing conversation, it is not necessary to quote me. That implies that you are referring to the context that was being discussed.

I quoted you saying that it was "hard to diagnose that early". That is what I disagreed with. It is not hard, and it requires no input from the patient.

 

[faire_jour]

You can easily check for yourself. Doesn't require any special skills.

I am asking you to back up your word. I am asking politely. Can you please show any kind of proof that a surgeon is not permitted to implant outside the age guidelines without special permission from the FDA?