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‘WATCHFUL WAITING WITH
AMPLIFICATION/ HEARING
AUGMENTATION’
Proposal for research study
Dr Tamsin Brown, Mr Roger Gray, Dr David Baguely.
1st November 2014
Reasons for the Study:
Children with chronic fluctuating hearing loss are at risk of
 “Long term consequences of language impairment” [1, 12];
 Educational difficulties (phonics, reading, spelling) [7, 8,9]
 Auditory Processing Difficulties/ deficit “as a result of conductive hearing
loss” [10]
 Self- esteem and Behavioural problems (Hyperactivity, Inattention) [11]
 Socio-communicative difficulties [12]
Currently the children with these problems are monitored with ‘watchful waiting’ and
advice until ventilation tubes/ grommets are inserted or hearing aids are considered.
Hearing aids are not often used as an option; they have the potential of over
amplifying and requiring multiple appointments.
This study is considering that a removable, small, one-size-fits-all soft band bone
conducting aid may be able to be used during the watchful waiting period to improve
language and developmental outcomes in these children. It would be expected that the
children who have multiple/recurring episodes of OME and are at greater risk of
learning problems and academic difficulties would benefit the most.
“The lack of awareness given to the full spectrum of paediatric hearing losses has
allowed numerous children with hearing impairment to go underserved in their
educational setting…When a child has a hearing impairment of early onset, even of a
relatively mild degree, development of these skills is often delayed. Such delays and
adversely affect communicative, academic and social success.” [4]
NICE guidelines have stated that “research is needed to accurately measure the
developmental impact of persistent bilateral OME in children” [5].
Chronic fluctuating hearing loss, defined by variable hearing loss with recurrent otitis
media with effusion, is often mild-to-moderate. OME is caused by viral Upper
Respiratory Tract Infections (URTI’s), acute otitis media and chronic eustachian tube
dysfunction.
The NICE guidelines state “otitis media with effusion (OME) is a common condition
of early childhood in which an accumulation of fluid within the middle ear space
causes hearing impairment. The hearing loss is usually transient and self-limiting over
several weeks, but may be more persistent and lead to educational, language and
behavioural problems” [5]
Research by Holm and Kunze [6] showed that children aged 5-9 years with chronic
otitis media were “delayed to a statistically significant degree in all language skills”.
Targeted age-group: The children under six years old are the children still
developing speech and language skills, as well as attending/listening skills/isolating
important sounds (for example of the teacher) over background noise. Children at
preschool or reception class or year one at school will be concentrating on phonics
and starting to learn to read, which means they are learning specific language skills at
a critical time in education: this happens to be a time when classroom noise can be up
to 70 dB (information from www.hear-it.org) and SATS/ national exams are
measured when a child aged 6-7years old. Children of this age cannot read to mitigate
the impact of hearing impairment on their learning. Approximately one third of
children are referred to audiology services by speech therapists (2014 Cambridge
data from our service) and of the children referred by other professionals 65% have
speech and language concerns: Speech and Language therapy would be better
supported with hearing assistance.
Period of time of expected hearing augmentation to be covered: While a child
waits for grommet insertion. If a child waits for the parent/ SaLT/ GP to refer into the
audiology service, then waits for the initial appointment, then waits 6 months (in 2 x 3
month blocks) in the community before being referred to ENT, there is a 6 week wait
to see ENT services and often the decision there is either
1) Watchful Waiting
2) Hearing aids (risking over-amplification/ cost of audiology appointments)
3) Ventilation tubes/ Grommets
If grommets are decided upon, then the patient has to wait for the operation.
(Sometimes the operation is delayed by child being unwell, cancellations etc.) The
time taken to receive grommets is 9-12 months or longer. That waiting time is a large
proportion of the child’s life, at a time of critical language or educational
development.
Maybe the child who waits unaided for 9-12 months and receives grommet insertion
has a good chance of catching up with speech and language skills; educational
attainment; listening/ processing skills, with unrecognisable long term consequences.
But Community Paediatricians are used to seeing children in clinic with long term
fluctuating hearing loss/ multiple grommets/ chronic perforations/ with a history of
being seen multiple times in the community paediatric audiology services and
intermittently by ENT services, who have a combination of the following…
 Speech and Language delay
 Auditory processing difficulties
 Poor educational attainment
 Poor reading skills
 Sociocommunication concerns (sometimes leading to assessments for Autism)
 Features of ADHD (Attention and hyperactivity Disorder) – see separate sheet
describing how mild hearing loss mimics ADHD
 Behavioural problems
 Low self esteem
By being able to give all children with conductive hearing loss some hearing support,
it is those children who will continue to have a longer fluctuating course (reported as
63% of children have more than one recurrence of otitis media in American data)
who will be best served. For this reason the study may be considered in 2 parts (if
funding allows); a short term study and a longer term (possibly 2-5 year?) study to
assess those with recurrent OME.
Aims of this study
To measure whether amplification/hearing augmentation using a bone conducting soft
band aid, over the watchful waiting period, improves speech and language and other
developmental outcomes.
The aim of the study will be to look at two groups of children, one group who is
randomised to receive a working soft band bone conductor, and the second group who
are randomised to receive either a ‘sham’/ disabled soft band bone conductor or (if
this is deemed unsuitable/unethical/too costly) no intervention at all prior to
grommets. The benefits of a sham bone conducting aid are that the study will be able
to be blinded by the children/families as well as those assessing outcome.
Qualities of the study
Good quality measurements of development, speech and language, self-esteem and
academic performance that other health professionals will trust, will be used. These
will need to be discussed further.
NICE guidance [5] asks that “ markers of developmental impact between hearing
(narrow, probably short-term) and speech/language and behaviour (broad, probably
long-term) should also be considered.” [5]
Ethical Considerations
1) Can a ‘sham’ bone conductor be used ethically?
2) Will there be a safety concern with children wearing a bone conductor be able
to locate the direction of sound (e.g. crossing the road)? Will a bone conductor
interfere with that developing process of sound location in a young child?
Limitations of the study
In the short time frame of watchful waiting until grommets, 9-12 months, is it possible
to reliably show a difference in development regardless of intervention? It may be
possible for a lot of children to catch up with a year of developmental delay. It may
be that the study will be useful in two parts: one with short-term results and one with
longer term results. It may be easier to show over a longer period of time (those with
recurring 0ME) to see a measurable difference in developmental and speech and
language outcomes between the two groups.
Biological plausibility
Chronic fluctuating hearing loss is common (The Massachusetts Eye and Ear institute
report up to “12% of children” in the united states have “at least one bout of otitis
media severe enough to cause a brief mild conductive hearing loss before reaching 5
years of age” as obtained from paediatric audiology studies and U.S. census data) and
its potential effects are documented worldwide. Education and audiology departments
are aware of its potential impact. A study [2] looking at early hearing loss and
language abilities in children with Down syndrome found that “the group who had
early hearing difficulties achieved lower scores than the group who had satisfactory
hearing on all the tests”. Community paediatricians cope with the referrals of children
whose development, speech, behaviour, learning and self-esteem have been affected
by the long-term consequences of chronic fluctuating hearing loss. A soft band bone
conducting aid would bypass their problem area/middle ear, thereby stimulating the
inner ear without any danger of over amplification. The possibility of a ‘standard’ soft
band being given to patients at community audiology appointments, without the need
for increasing the burden to audiology services or the expense of multiple hearing aid
appointments, could be possible in the future. It will suit children who have frequent
ear infections, discharge or perforations. Even if soft bands were not tolerated all day
by a child they could be used for school lessons or speech and language therapy or car
journeys/ meal times where parents report difficulties with communicating. The
Department of health: Children with Special Health Needs Hearing Advisory Council
[3] has stated that “While we are not advancing any particular medical treatment we
are advocating for audiological and educational intervention. In our experience,
children with chronic otitis media, unilateral hearing loss or mild hearing loss can
have difficulty learning in a noisy environment. Moreover, it has been well
established that support in the early years is critical to listening and language
learning.”
Future possibilities
To work with soft band bone conduction companies to produce a smaller, cheaper,
comfortable one-size-fits-all (adjustable strap?) soft band option that can be made
more widely available.
This study would not be an alternative to grommets. However, it is possible that this
study will lend support to longer term non-invasive management of this group of
children; could such bone conducting hearing aids be grommet-sparing?
REFERENCES
1) Journal of ‘Nature Communications 4, doi:10.1038/ncomms3547
2) G Laws& A Hall (2014). Early hearing loss and language abilities in children
with Down syndrome. International Journal of Language and Communication
disorders. Early View. DOI: 10.1111/1460-6984.12
3) Department of health: Children with special health needs hearing advisory
Council. 108 Cherry Street, PO Box 70, Drawer 28. Burlington, VT 05402
www.infanthearing.com
4) Paediatric clinics of North America. Volume 46, issue 1. Pages 143 – 152. 1
February 1999. ‘Considerations in the education of children with hearing loss.’
Noel D Matkin, PhD, Amy M Wilcox, MS.
5) Surgical Management of otitis media with effusion in children. Nice
guidelines [CG60] Published date: February 2008. guidance.nice.org.uk/cg60
6) Journal ‘Pediatrics 1969’ (Official Journal of the American Academy of
Pediatrics). Article ‘Effect of Chronic Otitis Media on Language and Speech
Development’. Authors: Vanja A Holm, LuVern H. Kunze. December 27
1968. Website: paediatrics.aappublications.org
7) Catts HW, Fey ME, Tomblin JB, ZhangX. A longitudinal invesitagtion of
reading outcomes in children with language impairments. J Speech Lang Hear
Res. 2002; 45(6): 1142-1157
8) Scarborough HS, Dobrich W. Development of children with early language
delay. J Speech Hear Res 1990;33(1): 70-83
9) Silva PA, Williams S, McGee R. A longitudinal study of children with
developmental language delay at age three: later intelligence, reading and
behaviour problems. Dev Med Child Neurol 1987;29(5): 630-640
10) James Jerger, Frank Musiek. Report of the Consensus Conference on the
Diagnosis of Auditory Processing Disorders in School-Aged Children. J Am
Acad Audiol 11:467-474 (2000)
11) Adesman AR, Altshuler LA, Lipkin PH, Walco GA. Otitis Media in children
with learning disabilities and in children with attention deficit disorder with
hyperactivity. Pediatrics. 1990 Mar;85(3 Pt2): 442-6.
12) Kazuhiro Tajima-Pozo, Diana Zambrano-Enriquez, Laura De Anta, Julie
Zelamnova, Jose Luis De Dois Vega. Otitis and autism spectrum disorders.
BMJ Case Reports 2010; doi:10.1136/bcr.10.2009.2351
Other relevant articles
DVM Bishop, A Edmundson. Is Otitis Media a major cause of specific
developmental language disorders? International Journal of Language and
Communication Disorders. Vol 21: Issue 3:Pages 321-338 (volume
publication :1986) DOI: 10.3109/13682828609019845
Articles needed (Not yet read – blocked out/ payment required):
1) Language, Speech Sound Production and Cognition in Three-Year-Old
Children in relation to Otitis Media in their first year of life. Paradise et al.
Pediatrics 2000; 105:5 1119-1130
2) Reading performance in children with otitis media.olaryngol Head Neck Surg
2005; 132:3 495-499
3) Early Ear Problems and Developmental Problems at school Age. CLIN
PEDIATR 1999; 38:3 123-132
4) Reading skills and Auditory Processing Ability in Children with Chronic
Otitis Media in Early Childhood. Ann Otol Rhinol laryngol 1992; 101:6 530537.
5) Auditory Dysfunction: In Children with School Problems. CLIN PEDIATR
1989; 28.9 397-403
6) Otitis Media: Effect on a Child’s learning. Intervention in School and Clinic
1986; 21:3 283-291
7) An Intervention ti Improve Follow up of Patients with Otitis Media. CLIN
PEDIATR 1985; 24:3 149-152
8) Learning Disabilities and Conductive Hearing Loss Involving Otitis Media. J
Learn Disabil 1983; 16:5 272-278
9) Some Developmental and Behavioural Problems Associated With Bilateral
Otitis Media with effusion. J Learn Disabil 1982; 15:7 417-421
10) Recurrent Middle Ear Effusion in Childhood: Implications of Temporary
Auditory Deprivation for Language and Learning. Ann Otol Rhinol Laryngol
1981; 90:6 546-551
11) Negative Middle Ear Pressure and Language Development: Some
observations. CLIN PEDIATR 1979; 18:5 296-297
12) Middle Ear Pathology as a Factor in Learning Disabilities. J Learn Disabil
1978; 11:2 103-106
ADDITIONAL INFORMATION MENTIONED IN PROPOSAL
Similarities between Mild Hearing loss and ADHD
ADHD
1) Blurting out answers spontaneously/ interrupting others
2) Difficulty completing tasks and organising tasks appropriately
3) Difficulty listening to others
4) Impulsive
5) Requires frequent reinforcement
6) Impacts on school learning
7) Can’t sit still and listen
8) Figety
Mild hearing loss
1) Interrupting others since are not fully engaged in conversation or make the
mistake of thinking a conversational pause is a chance to speak. Inappropriate
replies if hasn’t quite understood conversation
2) Difficulty following through instructions and sustaining attention
3) Difficulty listening to others
4) Appears to do things impulsively due to not hearing or boredom with not
being able to sustain extra concentration needed to follow a conversation with
a mild hearing loss
5) Requires repetition
6) Impacts on school learning
7) Poor listening skills
8) Becomes bored and therefore fidgety
‘I can include anonymised case presentations from a number of patients I have seen in
Cambridge (since I moved to the department in June this year) that have the problems
listed above alongside a history of chronic fluctuating hearing loss.’