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Worksheet Summary for Middle Ear/Conductive Hearing Loss

(1) Based on data and experience, develop list of otologic conditions to be targeted in the next 5 to 10 years. Include rationale.
Disease/Disorder/
Condition/ Target
Public Health Significance
e.g., high prevalence, severity, limited treatment options
Treatment Options e.g., none, ineffective, low benefit/risk ratio Disease Severity e.g., dire consequences, dire disabilities, compromised QOL Evidence Base e.g., none, some, limited Stage of readiness for research involving humans
Acute Otitis Media High prevalence low morbidity, high cost

- Prevnar, Pneumovax
- other vaccines
- antibiotics
- observation
- tympanocentesis (acute)
- symptomatic
- tubes for repeated AOM
- smoking cessession
- Day care, allergy management
- Adenoidectomy - recurrent
- Some "CAM" interventions

Usually mild but some complications can be serious: facial paralysis, meningitis, perforation, hearing loss Moderate support for observation over antibiotics (Evidence B)
Good support for tubes for recurrent (Evid. B)
Vaccines (Evidence ?) Adenoidectomy (Evidence D)
High
Requires large cohorts Replication of European studies.
Otitis Media with Effusion Low morbidity high prevalence, high cost

- antibiotics
- long term antibiotics
- tubes
- adenoidectomy
- allergy Rx
- reflux Rx
- "CAM" options

Mild hearing loss but long term consequences of language delay and middle ear complications

Generally good. But controversial. Depends on outcome measure. Excellent. Human Genetics. Animal work in this entity is not necessarily pertinent to humans. Infectious (including biofilm disease) vs. anatomical issues. Vaccines, allergy. Eustachian tube function? Studies of long term auditory processing still needed.
Congenital Syndromic ME problems low prevalence high individual impact Atresia, ossicular anomalies,
x-linked
- Surgical
- unsatisfying
- BoneAnchored Hearing Aid
Can be debilitating, recurrent surgeries. Multiple specialists. BC aids not satisfactory. Unilateral dz mild. Bilateral dz severe Evidence level C (minimal) Only applicable to humans
Atelectasis/ Retraction Eustachian tube problems uncommon but difficult management problems Limited.
- Allergy treatment
- adenoidectomy
- reconsturctive surgery
Much understanding through human temporal bone labs. Mild to severe individually. Uncommon complication of otitis syndromes. Evidence - case series, level C and some D Possibly yes. Hampered by low incidence. Eustachian tuboplasty? Adenoidectomy? Medical Rx, surfactants, mucolytics
Ossicular reconstruction? low prevalence low morbidity (CHL) Many forms of ossicular reconstruction/prostheses. Moderate - conductive hearing losses

Evidence B-C

Good. Innovations - few.
Cholesteatoma low prevalence, high severity and morbidity Surgical resection Relatively severe requiring surgery. No non-surgical therapies used. Often chronic HL and problems with lifelong otorrhea. Potential CNS complications Empirical Anecdotal. Evidence level C Ready but no good ideas.
Otitis Externa 5 low severity but very common topical antibiotics mostly effective mild to moderate Evidence B. Pharma Good. Innovations - few.

Otosclerosis/
Osteogenesis Imperfecta

Pagets
5 1/300 people. Progressive loss and hearing morbidity conductive - excellent development of stapes procedure. Poor understanding of medical treatment Causes progressive hearing loss. Range - conductive hearing loss to severe SN loss. Much understanding through human temporal bone labs.

For surgery aimed at conductive loss is good Evidence B.

For SN loss - fluorides or bisphosphonates.
Very good for large scale RCT - fluorides or bisphosphonates.
Tympanic membrane perforation reconstruction

5 common complication of OM and tubes. Low morbidity

Grafting fibrous material, cartilage, alloderm, fat paper patch

moderate - hearing loss and infections

Evidence B different materials used Good. Growth factors, graft materials
Post-tympanostomy tube otorrhea 6 -Topical antibiotic drops
- Antimicrobial ear tubes
- Prophylactic gtts.
Mild. Some children with prior history of AOM are worse. Some evidence for Gtts and antimicrobial tubes Good. Need better strategies for recurrent infection prevention. Can ONLY be done in humans

(2) For each target otologic condition, categorize the current state of knowledge regarding the condition and its interventions (if any) and the stage of research necessary for full development of the intervention.
Disease/
Disorder/
Condition Target
Understanding of Dz/Disorder/ Condition e.g., natural hx, treatment altering natural course Understanding of patho-physiology Is there a therapeutic targett Is there Intervention geared to therapeutic target Describe intervention: any modality e.g., surgery, drug, device, drug, behavior Stage of development of intervention e.g., basic understanding/early translation, preclinical, clinical, definitive clinical trials, late translation
Acute Otitis Media

Moderate. Questions exist about genetics, biofilm disease, viral etiologies, immunocom-petency. Extensive information about some pathogens.

Poor. Questions of genetics, eustachian tube dysfunction, bacterial biofilm/ colonies Yes. Bacteria, mucins, viruses, environment/ habits Some NO: genetic factors. Yes but not satisfactory. Prevention strategies - some understood Avoid smoking parents, avoid daycare, possible role of vaccines Over- prescription of antibiotics a problem All available for widespread testing. Definitive studies require large multicenter studies.
Otitis Media with Effusion

Lots of evidence but some conflicting.
- Role of adenoidectomy

- Role of antibiotics
Conflicted: bacterial, viral, eustachian tube, allergy, genetic. Several.
Root cause(s) unclear
Yes - some bacterial, yes for allergic, no for viral, no for ET, no for biofilm.
Pragmatic Rx (tubes) established
antibiotica, tubes, allergic management, adenoidectomy

Available but new strategies are needed. Some strategies are ineffective but widely used (antibiotics, steroids, decongestants late translation to practitioners issues

Congenital Syndromic ME problems Good understanding of anatomy, some understanding of genetics of syndromes but little insight into genetics of atresia. Much understanding through human temporal bone labs. Good Developmental Anatomically - yes. Genetically - no or unsure Yes but not satisfactory Surgery, BAHA. Innovative procedures by surgeons and BAHA development.
Hearing aid development
Atelectasis/ Retraction Eustachian tube problems Poor. Unsure of genetic contribution to ET dysfunction. Pathophysiology of ET dysfunction? Poor. Yes - eustachian tube function. Yes. Empiric. Ventilation, reconstruction Rudimentary
Ossicular reconstruction Good. Clinical and imaging Good Yes. Mechanical reconstructive techniques, adhesives. Compromised by ET function problems and inflammatory disease. Yes. Mechanical prostheses. Biocompatible tissue cement. Unsure of ME ventilation Mature - late translation to practitioners
Cholesteatoma Good in animal models and through human temporal bone histopathology. Good but various mechanisms cause controversy. Congenital cholesteatoma poorly understood. Keratinocytes? Early detection/ diagnosis Early detection is a major problem. Earlier detection more satisfactory? Visual markers for keratinocytes (during surgery) Surgery - type of surgery. Evidence for second looks? Empirical, but improvements in imaging technology may improve diagnosis and management. Early detection - little progress. Prevention - unknown. Unsure if tubes prevent
Otitis Externa Good Good Yes - Bacteria/ fungi Yes Appropriate antimiobials and steroids Good. Some opportunities for very very recalcitrant cases.
Otosclerosis/
Osteogenesis Imperfecta?
Pagets
Incomplete. Most understanding from human temporal bone histopathology. Genetic disorder but several loci map but no genes identified; viral etiology also possible. OI better genetic understanding. Paget's Disease poorly understood - unsure if viral. Anatomically good - bone remodeling of the otic capsule. Molecular mechanism not understood - genetic viral. Yes. Bone cells osteoclasts/ blasts Yes Fluorides and bisphosphonates Knowledge of reconstructive procedures is good (post translation) Mechanism of fluorides
Poorly understood. Mechanism of bisphosphonates is good.
Tympanic membrane perforation Good. Most understanding from clinical observations and human temporal bone histopathology. Good. Some healing issues. Wound healing research incomplete Yes - fibrous and epithelial growth. Spontaneous closure ? Mechanism Yes Common clinical practice - grafting surgery Fairly mature - late translation to practitioners standard of care. Room for improvement.
Post tympanostomy tube otorrhea Moderate - bacterial etiology but question the role of biofilm. Moderate. Unsure how infections persist Yes - bacteria in various phenotypes (sessile and planktonic) Yes but not entirely satisfactory Remove tubes, antibiotics, prevention Primary care docs giving oral antibiotics inappropriately Not following evidence

Electromecha-nical implants (ME procedure for inner ear problems - see inner ear group)

           

“?” = unresolved among workshop participants