Technological advancements have made it possible to identify hearing loss much early in life, ie; soon after birth. The early identification and intervention procedures initiated within six months of age would be the golden standard for the holistic development of a child with hearing loss.
One of the most dramatic developments in hearing and deafness has been the invention of cochlear implant. Over the past 35 years, the idea of restoring hearing to profoundly deaf patients by artificially stimulating the sensory system has now become a reality. Children with pre-lingual deafness do exceptionally well with cochlear implants and progress to acquire spoken language and produce intelligible speech.
In order to ensure optimum benefit hearing loss will have to be detected early and intervention should be started without loss of time. Lack of awareness at all levels about the overriding need for early detection of hearing impairment and early intervention, leads to late referral, thereby reducing the benefits of intervention.
A successful cochlear implant programme involves many steps from hearing screening to post operative rehabilitation. A coordinated multi - disciplinary approach is essential to ensure optimal outcomes. A successful cochlear implant programme cannot occur without a well resourced neonatal hearing screening programme, coordinated assessment programmes by audiology, speech pathology, educational and medical services and a dedicated audiology verbal therapy team for rehabilitation.
Cochlear implantation is expensive and in addition to the cost of implant material there would be the expenses of surgery, post operative care, audiological mapping, trouble shooting and post implant habilitation.
There are a number of factors that determine the degree of success to expect from the operation and the device itself. Cochlear implant centres determine implant candidacy on an individual basis and take into account a person’s hearing history, cause of hearing loss, amount of residual hearing, speech recognition ability, health status and family commitment to aural habilitation/ rehabilitation. It is on taking all this into account that the eligibility criteria have been laid down.
The eligibility criteria under the scheme are given below:
1. The child should be in the age group of 0-3 years. However the Screening Committee would be empowered to make exceptions beyond 3 years up to 5 years of age on a case to case basis; where the committee feel that a high possibility of success exists or if there are other compelling technical reasons warranting or making an exception.
2. The annual family income of the applicant should be below Rs. 2 Lakhs.
3. The applicant / parent should be a permanent resident of Kerala.
4. The child should be certified by a competent authority (under the scheme) regarding need for cochlear implantation surgery. There should not be any medical contradictions to surgery and or implantation.
5. The parents of the child should be prepared to undergo a mandatory training on speech therapy and post operative care.
6. Parents or Guardian of the child should give an under taking, in 100 rupees stamp paper, in the prescribed format as given in annexure 1.
a). Institutions and specific doctors would be empanelled by Health & FW Department for screening / detection of children with hearing impairment. On empanelment the concerned centre would be ‘competent authority’ to certify the need of the child for Cochlear implantation surgery.
b). The rates/charges for audiological test to determine extent of hearing loss will be notified by Health & FW Department with a view to ensuring uniformity.
c). The Child Development Centre (CDC) will develop and rollout a community based programme model for early detection of hearing disability among children below the age of 3 years through the Anganwadi network. All children at risk should be referred to nearby audiological centre for screening.
d). The costs of audiological tests for detection would have to be borne by the applicants.
e). The parents/guardian of the child detected of hearing impairment, with a high chance of success after implantation may apply for cochlear implantation, to Kerala Social Security Mission (KSSM), in the prescribed format (Annex-2)
f). The Executive Director, Kerala Social Security Mission will convene State Level Technical committee for selection of suitable candidates for Cochlear implantation.
g). The Health and FW Department will set up three inspection committee for empanelment for private hospitals.
h). Early cochlear implantation is essential to children who have developed hearing impairment due to Meningitis. Otherwise child will develop ossification of cochlea and eventually became unfit for cochlear implantation. To address this issue, a separate panel will be formed in each region consisting of a cochlear implant surgeons/ Professor of ENT from the Govt. Medical colleges in the region and implant surgeons from empanelled hospitals. Executive Director, Kerala Social Security Mission can permit cochlear implantation of these children immediately as a special case, based on the recommendation of treating doctor and an expert panellist from Government Medical College, without considering priority on the basis of age. Such cases should be ratified in next State Level Technical committee. The Health & Family Welfare Department will issue a Government order based on the proposal submitted by Executive Director, Kerala Social Security Mission.
Health & Family Welfare Department will empanel hospitals and doctors considering their facilities for cochlear implantation surgery and rehabilitation, altogether. Hospital seeking for empanelment should apply in the prescribed application form as given in annexure 3.
a) Properly filled application with necessary documents should be submitted to Executive Director, Kerala Social Security Mission and the same will be forwarded to concerned regional inspection committee.
b) Inspection team will visit the hospital for physical verification of facilities and records. They will recommend empanelment considering all the three basic requirements for cochlear implant surgery ie, cochlear implant surgeon with adequate experiences, adequate infrastructure, instruments, equipments and facilities for implantation surgery and auditory verbal habilitation.
c) Any ENT surgeon who had performed 10 cochlear implant surgeries independently, with FDA (Food and drug administration) of USA approved implants will be considered as surgeon with adequate experiences.
d) All the requirements mentioned in the section 10,11,13 of the application form for empanelment is essential to meet the criteria for adequate infrastructure, instruments , equipments and facilities for implantation surgery and auditory verbal habilitation, except dual channel audiometry and laminar air flow. Relaxation for 1 year will be given to develop/install above the facilities/equipment from the date of this order.
e). Hospitals seeking empanelment should have either their own facilities for auditory verbal habilitation or should have tie up with centres with the manpower and facilities mentioned in the application form for empanelment.
f). Regional Inspection Committees will submit the inspection report to Kerala social Security Mission. Application recommended by Regional Inspection Committee will be forwarded to Health & FW Department for necessary orders.
g) Government medical college Kozhikode will be an approved centre for cochlear implantation programme as there is adequate expertise and infrastructure for cochlear implantation surgery. Other medical colleges will also be empanelled as and when they develop adequate expertise and manpower
h) Kerala Social Security Mission will prepare a format for memorandum of Understanding (MOU) with the empanelled hospitals based on this Government Order and other terms and conditions essential for smooth and successful implementation of the project. Empanelled hospitals should sign MOU with the Executive Director, KSSM.
i) Empanelment should be reviewed every two years or in the event of empanelled doctor leaving the institution. However the responsibility of auditory verbal habilitation of already operated children rest with the empanelled doctor who performed surgery. He should arrange further follow up of children either in same hospitals or another empanelled hospital.
The State Level Technical Committee will be constituted by the Health and Family Welfare Department to (a) shall finalise the selection of implants (b) develop TOR for empanelment of institutions and doctors (c) give technical advice to Govt. in the implementation of the scheme, (d) recommend standards and specifications, suppliers, rates and terms and conditions of procurement of cochlear implant devices, (e) laying down strict protocol for diagnosis and detection, intervention and rehabilitation, (f). The State Level Technical committee will be responsible for the selection of candidates suitable for cochlear implantation after scrutinising the applications and relevant records on the basis of the criteria of selection for cochlear implantation, preoperative assessment and investigation reports.
Executive Director, KSSM will be the convener of the committee, other members are Executive Director, NISH, two ENT professors from Government medical colleges and one ENT surgeon with implant experience from private sector. Committee is empowered to invite audiologist from Government sector for technical assistance during technical committee meeting. The State Level Technical committee are also empowered to call the child during the selection committee meeting for clinical assessment and counselling if required.
a). Bilateral profound sensory neural hearing loss in children in the age group of 12 months to 18 months.
b). Bilateral severe to profound sensory neural hearing loss in children in the age group of 18 months and above. Preferably before 3 years.
c). However the Screening Committee would be empowered to make exceptions on a case to case basis; when the committee feel that a high possibility of success exists or if there are other compelling technical reasons warranting for making an exception.
d). No or little benefit from strong power hearing aid after speech therapy for at least for 3 months.
e). No associated cognitive impairment
f). No medical or anatomical contra indication.
g). Motivated parents to attend auditory verbal habilitation.
The preoperative assessment should include the following
• Audiological Evaluation
• Speech pathology assessment
• Otological Evaluation
• Intensive Speech therapy with properly fitting hearing aid, at least for three months.
• Initial family counselling.
• Anatomical evaluation
The preoperative investigation should include the following
1. BERA/ audiogram
2. ASSR
3. OAE
4. Tympanogram
5. Aided threshold BOA / audiogram
6. Speech – language test
7. HRCT of the temporal bone
8. MRI of head & inner ear.
Candidates for cochlear implantation need to be informed of the potential risks and benefits of cochlear-implantation and the impact it may have on their life. The surgical procedure and its risks should be described along with a physical description and, preferable demonstration, of the internal and external portions of the device. The post surgical programming and rehabilitation procedures should be charted out and informed to the parents. The most important aspect here is to give a realistic expectation regarding performance outcome with the implant.
a). The empanelled hospital will do the surgery according to the selection list prepared by Kerala Social Security Mission. Implants will be supplied to concerned hospitals by selected firms according to the supply orders issued by KSSM. After completion of surgery, the concerned hospitals should submit Delivery chalan, Operative note and a copy of implant registration form. Kerala Social Security Mission will release the payment to concerned cochlear companies after obtaining delivery chalan from hospitals and invoice from concerned companies.
b) Empanelled private hospitals will be permitted to charge an amount fixed by empowerment committee for surgery and post operative management from time to time. No other charges should be collected from parents for surgery and post operative care.
c) As and when required, empanelled private hospitals should permit two ENT surgeons and an audiologist from medical education department as observers during each implantation surgery under the scheme.
d). Empanelled government hospitals will meet cost of drugs and investigation which are not available in the hospital from HDS fund.
The choice of institutions for surgery will be done by the Kerala Social Security Mission after considering following factors.
(a). Interest of the parents.
(b). Willingness to pay the amount fixed by the Empowered committee if they are opting a private hospital.
Based on the recommendation of state level technical committee, Executive Director, KSSM will prepare centre wise priority list of selected candidates for surgery and allot the cases to concerned centres. Allotment list will be prepared in the prescribed format (Annexure – 4) and should be placed in the next State Level monitoring committee for ratification.
a). Empanelled hospitals will be responsible for mapping and two year long auditory habilitation. Empowered committee will decide charges for mapping and two year long auditory habilitation from time to time. Kerala Social Security Mission will release the amount in four instalments to private hospitals. The first instalment, (40 %) will be released after getting copy of product registration and mapping report from concerned hospitals. Balance amount will be released in three equal instalments at six months interval after getting periodical progress and follow up reports from concerned hospitals. No amount should be collected from parents for auditory verbal habilitation. Each centre should provide at least two sessions of AVT/child/week for two years. Duration of each session should be at least one hour. Programming should be done as per the protocol specified by concerned cochlear companies.
b). No amount will be released to Government Hospitals for AVH; KSSM will provide minimum number of speech therapist on contract basis.
c). Transfer of candidates from one empanelled centre to another empanelled centre will be permitted by ED KSSM, 6 months after switch on , on the request of the parents in the prescribed format (Annexure – 5).
The scheme will be jointly implemented by Social Welfare Department & Health and Family Welfare Department. Secretary (Social Welfare) will be the Nodal Officer and K.S.S.M will be the nodal agency.
Empowered committee with Minister (Panchayath & Social Welfare) as Chairman and Minister (Health & FW) as Co Chairman will be the supreme authority for making the policy decisions.
The Empowered committee will fix the surgery charges for private hospitals from time to time. Empowered committee will decide the charges for mapping and the two year long auditory habilitation from time to time.
State Level Monitoring Committee chaired by the Secretary, Social Welfare will monitor the implementation of the programme.
The following are the members of Empowered Committee:
There will be a State Level Committee for (a) monitoring and review of implementation, (b) grievance redressal.
The composition of the committee will be as below:
To support children above five years, Mission will provide cochlear implants for surgeries in empanelled hospitals if the cost of the implant is paid to Kerala Social Security Mission by a sponsor/ organisation/ individual/ family. Cost of AVT and surgery charges also should be beared by either parents or sponsor. Sponsor and parents should submit an application in this regard in the prescribed format (Annexure – 6).