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(1) Based on data and experience, develop list of otologic conditions to be targeted in the next 5 to 10 years. Include rationale.
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| 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 |
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 |
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. |
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Otosclerosis/ |
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 |
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(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.
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| 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. |
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 |
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Electromecha-nical implants (ME procedure for inner ear problems - see inner ear group) |
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“?” = unresolved among workshop participants
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